SARS-CoV-2 InfectionPhase 2COVID-19NCT05112848
A Study to Evaluate Safety and Immunogenicity of a COVID-19 Vaccine in People Living With HIV at Risk for SARS-CoV-2 (COVID-19)
A Phase 2 study testing NVX-CoV2373 in people with SARS-CoV-2 Infection, run by Novavax at 7 sites in South Africa.
Trial summary
This is a Phase 2, randomized, observer-blinded study evaluating the safety and immunogenicity of SARS-CoV-2 with Matrix-M™ Adjuvant in people living with human immunodeficiency virus (HIV) (PLWH) and HIV- negative adults, seronegative to SARS-CoV-2 at baseline. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- SARS-CoV-2 Infection
- What is being tested?
- NVX-CoV2373
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 7 sitesSouth Africa
- Study dates
- 28 Feb 2022to 30 Nov 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 to 65 years of age, inclusive, at screening.
- Willing and able to give informed consent prior to study enrollment and to comply with study procedures.
- Participants of childbearing potential (defined as any participant who has experienced menarche and who is NOT surgically sterile [ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months]) must agree to be heterosexually inactive from at least 28 days prior to enrollment and through the end of the study OR agree to consistently use a medically acceptable method of contraception listed below from at least 28 days prior to enrollment and through the end of the study.
- Condoms (male or female) with spermicide (if acceptable in-country)
- Diaphragm with spermicide
- Cervical cap with spermicide
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- Intrauterine device
- Oral or patch contraceptives
- Norplant®, Depo-Provera®, or other in-country regulatory approved contraceptive method that is designed to protect against pregnancy.
- Abstinence as a form of contraception is acceptable if in line with the participant's lifestyle.
- Vital signs must be within medically acceptable ranges prior to the first vaccination
- Agree to not participate in any other SARS-CoV-2 prevention or treatment trials for the duration of the study.
- For well-controlled PLWH
- PLWH with a cluster of differentiation 4 (CD4) + T-cell count of ≥ 350 cells/μL at screening or viral load of ≤ 1,000 copies/mL.
- PLWH being managed on a stable/unchanged antiretroviral therapy (ART) regimen for at least 2 months prior to enrollment.
- No opportunistic infections in the past year.
- For less-well-controlled PLWH
- PLWH with a CD4+ T-cell count of ≥ 200 and < 350 cells/μL at screening or viral load of 1,000 to 10,000 copies/mL.
- PLWH being managed on a stable/unchanged (ART) regimen for at least 1 month prior to enrollment.
Who cannot join
- Laboratory-confirmed SARS-CoV-2 infection (PCR+ within 5 days prior to first study vaccination with results available before randomization) or positive anti-S protein antibody to SARS-CoV-2 at screening.
- Previous receipt of any investigational or authorized/approved vaccine, prophylactic or therapeutic agent for the prevention or treatment of COVID-19.
- Participation in research involving receipt of an investigational product (drug/biologic/device) within 90 days prior to the first study vaccination.
- Received influenza vaccination within 14 days prior to first study vaccination, or any other vaccine within 30 days prior to first study vaccination.
- Any known allergies to products contained in the investigational product.
- Any history of anaphylaxis to any prior vaccine.
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- Autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) requiring ongoing immunomodulatory therapy.
- Chronic administration (defined as > 14 continuous days) of immunosuppressant, systemic glucocorticoids, or other immune-modifying drugs within 90 days prior to first study vaccination.
- Received immunoglobulin, blood-derived products, or immunosuppressant drugs within 90 days prior to first study vaccination.
- Active cancer (malignancy) on therapy within 3 years prior to first study vaccination (with the exception of adequately treated non-melanomatous skin carcinoma or lentigo maligna and uterine cervical carcinoma in situ without evidence of disease, at the discretion of the investigator).
- Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the end of study.
- Suspected or known history of alcohol abuse or drug addiction within 2 years prior to the first study vaccine dose that, in the opinion of the investigator, might interfere with protocol compliance.
- Any other condition that, in the opinion of the investigator, would pose a health risk to the participant if enrolled or could interfere with evaluation of the trial vaccine or interpretation of study results (including neurologic or psychiatric conditions likely to impair the quality of safety reporting).
- Study team member or immediate family member of any study team member (inclusive of Sponsor, Contract Research Organization, and study site personnel involved in the conduct or planning of the study).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Africa7 sites
Josha Research
Bloemfontein, Free State, 9301
Madibeng Centre for Research
Brits, North West, 250
Wits Vaccines & Infectious Diseases Analytics (VIDA) Research Unit
Diepkloof, Johannesburg, 1862
Wits RHI Shandukani Research Centre
Hillbrow, Johannesburg, 2001
MERC Research (Pty) Ltd - Middelburg
Middelburg, Mpumalanga, 1055
The Aurum Institute Pretoria Clinical Research Services
Pretoria, Gauteng, 0087
KwaPhila Health Solutions (Enhancing Care)
Westridge, Durban, 4091
About this study
Official title: A Phase 2, Randomized, Observer-Blinded Study to Evaluate the Safety and Immunogenicity of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) With Matrix-M™ Adjuvant in People Living With HIV
This is a Phase 2, randomized, observer-blinded study evaluating the safety and immunogenicity of SARS-CoV-2 with Matrix-M™ Adjuvant in people living with human immunodeficiency virus (HIV) (PLWH) and HIV- negative adults, seronegative to SARS-CoV-2 at baseline.
Read the detailed description
The investigational product will be a monovalent Serum Institute of India (SII) SARS CoV-2 vaccine at a dose of 5 µg antigen adjuvanted with 50 µg Matrix-M (referred hereafter as NVX-CoV2373).
Approximately 270 PLWH, 18 to 65 years of age inclusive, will be enrolled into 3 groups and stratified at presentation based on the level of control of HIV infection. All PLWH will be baseline seronegative (for SARS-CoV-2) and have not received any authorized SARS-CoV-2 vaccines. PLWH will be randomly assigned 1:1:1 to receive NVX-CoV2373 in either a two dose regimen on Days 0 and 21 or Days 0 and 70 or a three-dose regimen on Days 0, 21, and 70. Randomization of PLWH will be stratified by level of control of HIV infection to distribute well controlled and less well controlled participants approximately evenly among the 3 PLWH treatment groups. Approximately 90 HIV negative participants, 18 to 65 years of age inclusive, will be randomly assigned 1:1 to receive NVX-CoV2373 in a two dose regimen on Days 0 and 21 or Days 0 and 70. All HIV negative participants will be baseline seronegative (for SARS-CoV-2) and have not received any authorized SARS-CoV-2 vaccines. Placebo (normal saline solution) will be administered to participants who receive a two-dose regimen of NVX-CoV2373 to maintain overall blinding.
- Conditions
- SARS-CoV-2 Infection
- Being tested
- NVX-CoV2373
- Keywords
- Coronavirus disease 2019 (COVID-19), HIV
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NVX-CoV2373Biological
Also called Monovalent SARS-CoV-2 rS vaccine premixed with Matrix-M adjuvant
Alternating intramuscular (IM) (deltoid) injections of monovalent prototype vaccine premixed with Matrix-M™ adjuvant (0.5 mL) given either as
2 doses (one on Day 0 and one on Day 21 or Day 70) and an injection of placebo (0.5mL) on Day 21 or Day 70, or 3 doses (Day 0, Day 21, and Day 70).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 PLWH | Experimental | Two doses of 5μg monovalent prototype vaccine+50µg Matrix-M adjuvant, given on Day 0 and Day 21.
Alternating IM (deltoid) injection of placebo (0.5mL) given on Day 70. Receives: Biological: NVX-CoV2373 |
| Group 2 PLWH | Experimental | Three doses of 5μg monovalent prototype vaccine+50µg Matrix-M adjuvant, given on Day 0, Day 21, and Day 70. Receives: Biological: NVX-CoV2373 |
| Group 3 PLWH | Experimental | Two doses of 5μg monovalent prototype vaccine+50µg Matrix-M adjuvant, given on Day 0 and Day 70.
Alternating IM (deltoid) injection of placebo (0.5mL) given on Day 21. Receives: Biological: NVX-CoV2373 |
| Group 4 HIV-Negative Participants | Experimental | 2 doses of 5μg monovalent prototype vaccine+50µg Matrix-M adjuvant, given on Day 0 and Day 21.
Alternating IM (deltoid) injection of placebo (0.5mL) given on Day 70. Receives: Biological: NVX-CoV2373 |
| Group 5 HIV-Negative Participants | Experimental | Two doses of 5μg monovalent prototype vaccine+50µg Matrix-M adjuvant, given on Day 0 and Day 70.
Alternating IM (deltoid) injection of placebo (0.5mL) given on Day 21. Receives: Biological: NVX-CoV2373 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of PLWH with unsolicited adverse events (AEs)
Number of PLWH with unsolicited AEs stratified by level of control of HIV infection.
Measured: Day 84
Number of HIV-Negative participants with unsolicited AEs
Number of HIV-Negative participants with unsolicited AEs.
Measured: Day 84
Number of PLWH with unsolicited AEs
Number of PLWH with unsolicited AEs stratified by level of control of HIV infection.
Measured: Day 120
Number of PLWH with unsolicited AEs
Number of PLWH with unsolicited AEs stratified by level of control of HIV infection.
Measured: Day 180
Number of HIV-Negative participants with unsolicited AEs
Number of HIV-Negative participants with unsolicited AEs.
Measured: Day 120
Number of HIV-Negative participants with unsolicited AEs
Number of HIV-Negative participants with unsolicited AEs.
Measured: Day 180
Number of PLWH with solicited systemic AEs
Number of PLWH with solicited systemic AEs for 7 days following each vaccination stratified by baseline severity of disease as determined by the level of control of HIV infection into well-controlled and less-well-controlled treatment groups.
Measured: Day 0
Number of PLWH with solicited systemic AEs
Number of PLWH with solicited systemic AEs for 7 days following each vaccination stratified by baseline severity of disease as determined by the level of control of HIV infection into well-controlled and less-well-controlled treatment groups.
Measured: Day 21
Number of PLWH with solicited systemic AEs
Number of PLWH with solicited systemic AEs for 7 days following each vaccination stratified by baseline severity of disease as determined by the level of control of HIV infection into well-controlled and less-well-controlled treatment groups.
Measured: Day 70
Number of HIV-Negative participants with solicited systemic AEs
Number of HIV-Negative participants with solicited systemic AEs for 7 days following each vaccination.
Measured: Day 0
Number of HIV-Negative participants with solicited systemic AEs
Number of HIV-Negative participants with solicited systemic AEs for 7 days following each vaccination.
Measured: Day 21
Number of HIV-Negative participants with solicited systemic AEs
Number of HIV-Negative participants with solicited systemic AEs for 7 days following each vaccination.
Measured: Day 70
Number of PLWH with solicited local AEs
Number of PLWH with solicited local AEs for 7 days following each vaccination stratified by baseline severity of disease as determined by the level of control of HIV infection into well-controlled and less-well-controlled treatment groups.
Measured: Day 0
Number of PLWH with solicited local AEs
Number of PLWH with solicited local AEs for 7 days following each vaccination stratified by baseline severity of disease as determined by the level of control of HIV infection into well-controlled and less-well-controlled treatment groups.
Measured: Day 21
Number of PLWH with solicited local AEs
Number of PLWH with solicited local AEs for 7 days following each vaccination stratified by baseline severity of disease as determined by the level of control of HIV infection into well-controlled and less-well-controlled treatment groups.
Measured: Day 70
Number of HIV-Negative participants with solicited local AEs
Number of HIV-Negative participants with solicited local AEs for 7 days following each vaccination.
Measured: Day 0
Number of HIV-Negative participants with solicited local AEs
Number of HIV-Negative participants with solicited local AEs for 7 days following each vaccination.
Measured: Day 21
Number of HIV-Negative participants with solicited local AEs
Number of HIV-Negative participants with solicited local AEs for 7 days following each vaccination.
Measured: Day 70
Serum Immunoglobulin (IgG) antibody levels expressed as geometric mean enzyme-linked immunosorbent assay units (GMEU)
Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as GMEUs in PLWH stratified by level of control of HIV infection.
Measured: Day 21
Serum Immunoglobulin (IgG) antibody levels expressed as geometric mean enzyme-linked immunosorbent assay units (GMEU)
Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as GMEUs in PLWH stratified by level of control of HIV infection.
Measured: Day 35
Serum Immunoglobulin (IgG) antibody levels expressed as geometric mean enzyme-linked immunosorbent assay units (GMEU)
Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as GMEUs in PLWH stratified by level of control of HIV infection.
Measured: Day 70
Serum Immunoglobulin (IgG) antibody levels expressed as geometric mean enzyme-linked immunosorbent assay units (GMEU)
Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as GMEUs in PLWH stratified by level of control of HIV infection.
Measured: Day 84
Serum IgG antibody levels expressed as geometric mean fold rise (GMFR)
Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as GMFRs in PLWH stratified by level of control of HIV infection.
Measured: Day 21
Serum IgG antibody levels expressed as geometric mean fold rise (GMFR)
Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as GMFRs in PLWH stratified by level of control of HIV infection.
Measured: Day 35
Serum IgG antibody levels expressed as geometric mean fold rise (GMFR)
Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as GMFRs in PLWH stratified by level of control of HIV infection.
Measured: Day 70
Serum IgG antibody levels expressed as geometric mean fold rise (GMFR)
Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as GMFRs in PLWH stratified by level of control of HIV infection.
Measured: Day 84
Serum IgG antibody levels expressed as seroconversion rate (SCR)
Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as SCRs in PLWH stratified by level of control of HIV infection.
Measured: Day 21
Serum IgG antibody levels expressed as seroconversion rate (SCR)
Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as SCRs in PLWH stratified by level of control of HIV infection.
Measured: Day 35
Serum IgG antibody levels expressed as seroconversion rate (SCR)
Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as SCRs in PLWH stratified by level of control of HIV infection.
Measured: Day 70
Serum IgG antibody levels expressed as seroconversion rate (SCR)
Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as SCRs in PLWH stratified by level of control of HIV infection.
Measured: Day 84
Human angiotensin-converting enzyme 2 (hACE2) receptor binding inhibition assay expressed as geometric mean titer (GMT)
Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as GMT in PLWH stratified by level of control of HIV infection.
Measured: Day 21
Human angiotensin-converting enzyme 2 (hACE2) receptor binding inhibition assay expressed as geometric mean titer (GMT)
Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as GMT in PLWH stratified by level of control of HIV infection.
Measured: Day 35
Human angiotensin-converting enzyme 2 (hACE2) receptor binding inhibition assay expressed as geometric mean titer (GMT)
Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as GMT in PLWH stratified by level of control of HIV infection.
Measured: Day 70
Human angiotensin-converting enzyme 2 (hACE2) receptor binding inhibition assay expressed as geometric mean titer (GMT)
Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as GMT in PLWH stratified by level of control of HIV infection.
Measured: Day 84
hACE2 receptor binding inhibition assay expressed as GMFR
Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as GMFR in PLWH stratified by level of control of HIV infection.
Measured: Day 21
hACE2 receptor binding inhibition assay expressed as GMFR
Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as GMFR in PLWH stratified by level of control of HIV infection.
Measured: Day 35
hACE2 receptor binding inhibition assay expressed as GMFR
Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as GMFR in PLWH stratified by level of control of HIV infection.
Measured: Day 70
hACE2 receptor binding inhibition assay expressed as GMFR
Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as GMFR in PLWH stratified by level of control of HIV infection.
Measured: Day 84
hACE2 receptor binding inhibition assay expressed as SCR
Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as SCR in PLWH stratified by level of control of HIV infection.
Measured: Day 21
hACE2 receptor binding inhibition assay expressed as SCR
Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as SCR in PLWH stratified by level of control of HIV infection.
Measured: Day 35
hACE2 receptor binding inhibition assay expressed as SCR
Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as SCR in PLWH stratified by level of control of HIV infection.
Measured: Day 70
hACE2 receptor binding inhibition assay expressed as SCR
Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as SCR in PLWH stratified by level of control of HIV infection.
Measured: Day 84
Neutralizing antibody activity expressed as GMT
Titers of neutralizing antibody to the prototype virus expressed as GMT in PLWH stratified by level of control of HIV infection.
Measured: Day 35
Neutralizing antibody activity expressed as GMT
Titers of neutralizing antibody to the prototype virus expressed as GMT in PLWH stratified by level of control of HIV infection.
Measured: Day 84
Neutralizing antibody activity expressed as SCR
Titers of neutralizing antibody to the prototype virus expressed as SCR in PLWH stratified by level of control of HIV infection.
Measured: Day 35
Neutralizing antibody activity expressed as SCR
Titers of neutralizing antibody to the prototype virus expressed as SCR in PLWH stratified by level of control of HIV infection.
Measured: Day 84
Neutralizing antibody activity expressed as GMFR
Titers of neutralizing antibodies to the prototype virus expressed as GMFR in PLWH stratified by level of control of HIV infection.
Measured: Day 35
Neutralizing antibody activity expressed as GMFR
Titers of neutralizing antibodies to the prototype virus expressed as GMFR in PLWH stratified by level of control of HIV infection.
Measured: Day 84
Secondary outcomes (12)
Serum IgG antibody levels expressed as GMEU
Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as GMEUs in HIV-negative participants.
Measured: Day 21
Serum IgG antibody levels expressed as GMEU
Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as GMEUs in HIV-negative participants.
Measured: Day 35
Serum IgG antibody levels expressed as GMEU
Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as GMEUs in HIV-negative participants.
Measured: Day 70
Serum IgG antibody levels expressed as GMEU
Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as GMEUs in HIV-negative participants.
Measured: Day 84
Serum IgG antibody levels expressed as GMFR
Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as GMFR in HIV-negative participants.
Measured: Day 21
Serum IgG antibody levels expressed as GMFR
Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as GMFR in HIV-negative participants.
Measured: Day 35
Serum IgG antibody levels expressed as GMFR
Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as GMFR in HIV-negative participants.
Measured: Day 70
Serum IgG antibody levels expressed as GMFR
Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as GMFR in HIV-negative participants.
Measured: Day 84
Serum IgG antibody levels expressed as SCR
Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as SCR in HIV-negative participants.
Measured: Day 21
Serum IgG antibody levels expressed as SCR
Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as SCR in HIV-negative participants.
Measured: Day 35
Serum IgG antibody levels expressed as SCR
Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as SCR in HIV-negative participants.
Measured: Day 70
Serum IgG antibody levels expressed as SCR
Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as SCR in HIV-negative participants.
Measured: Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start28 Feb 2022
- Primary completion23 May 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novavax
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development, Study director, Novavax
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112848
- Sponsor's protocol ID
- 2019nCoV-505
- Acronym
- COVID-19
- Status last verified
- Mar 2023
- First submitted
- 25 Oct 2021
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Observer-Blinded Study to Evaluate the Safety and Immunogenicity of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) With Matrix-M™ Adjuvant in People Living With HIV
- ClinicalTrials.gov ID
- NCT05112848
- Acronym / sponsor ID
- COVID-19 / 2019nCoV-505
- Conditions
- SARS-CoV-2 Infection
- Keywords
- Coronavirus disease 2019 (COVID-19), HIV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- NovavaxIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 23 May 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 9 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2, randomized, observer-blinded study evaluating the safety and immunogenicity of SARS-CoV-2 with Matrix-M™ Adjuvant in people living with human immunodeficiency virus (HIV) (PLWH) and HIV- negative adults, seronegative to SARS-CoV-2 at baseline.
Detailed description
The investigational product will be a monovalent Serum Institute of India (SII) SARS CoV-2 vaccine at a dose of 5 µg antigen adjuvanted with 50 µg Matrix-M (referred hereafter as NVX-CoV2373).
Approximately 270 PLWH, 18 to 65 years of age inclusive, will be enrolled into 3 groups and stratified at presentation based on the level of control of HIV infection. All PLWH will be baseline seronegative (for SARS-CoV-2) and have not received any authorized SARS-CoV-2 vaccines. PLWH will be randomly assigned 1:1:1 to receive NVX-CoV2373 in either a two dose regimen on Days 0 and 21 or Days 0 and 70 or a three-dose regimen on Days 0, 21, and 70. Randomization of PLWH will be stratified by level of control of HIV infection to distribute well controlled and less well controlled participants approximately evenly among the 3 PLWH treatment groups. Approximately 90 HIV negative participants, 18 to 65 years of age inclusive, will be randomly assigned 1:1 to receive NVX-CoV2373 in a two dose regimen on Days 0 and 21 or Days 0 and 70. All HIV negative participants will be baseline seronegative (for SARS-CoV-2) and have not received any authorized SARS-CoV-2 vaccines. Placebo (normal saline solution) will be administered to participants who receive a two-dose regimen of NVX-CoV2373 to maintain overall blinding.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 PLWH | Experimental | Biological: NVX-CoV2373Two doses of 5μg monovalent prototype vaccine+50µg Matrix-M adjuvant, given on Day 0 and Day 21. Alternating IM (deltoid) injection of placebo (0.5mL) given on Day 70. |
| Group 2 PLWH | Experimental | Biological: NVX-CoV2373Three doses of 5μg monovalent prototype vaccine+50µg Matrix-M adjuvant, given on Day 0, Day 21, and Day 70. |
| Group 3 PLWH | Experimental | Biological: NVX-CoV2373Two doses of 5μg monovalent prototype vaccine+50µg Matrix-M adjuvant, given on Day 0 and Day 70. Alternating IM (deltoid) injection of placebo (0.5mL) given on Day 21. |
| Group 4 HIV-Negative Participants | Experimental | Biological: NVX-CoV23732 doses of 5μg monovalent prototype vaccine+50µg Matrix-M adjuvant, given on Day 0 and Day 21. Alternating IM (deltoid) injection of placebo (0.5mL) given on Day 70. |
| Group 5 HIV-Negative Participants | Experimental | Biological: NVX-CoV2373Two doses of 5μg monovalent prototype vaccine+50µg Matrix-M adjuvant, given on Day 0 and Day 70. Alternating IM (deltoid) injection of placebo (0.5mL) given on Day 21. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Adults 18 to 65 years of age, inclusive, at screening.
- Willing and able to give informed consent prior to study enrollment and to comply with study procedures.
- Participants of childbearing potential (defined as any participant who has experienced menarche and who is NOT surgically sterile [ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months]) must agree to be heterosexually inactive from at least 28 days prior to enrollment and through the end of the study OR agree to consistently use a medically acceptable method of contraception listed below from at least 28 days prior to enrollment and through the end of the study.
- Vital signs must be within medically acceptable ranges prior to the first vaccination
- Agree to not participate in any other SARS-CoV-2 prevention or treatment trials for the duration of the study.
Key exclusion criteria (14 listed)
- Laboratory-confirmed SARS-CoV-2 infection (PCR+ within 5 days prior to first study vaccination with results available before randomization) or positive anti-S protein antibody to SARS-CoV-2 at screening.
- Previous receipt of any investigational or authorized/approved vaccine, prophylactic or therapeutic agent for the prevention or treatment of COVID-19.
- Participation in research involving receipt of an investigational product (drug/biologic/device) within 90 days prior to the first study vaccination.
- Received influenza vaccination within 14 days prior to first study vaccination, or any other vaccine within 30 days prior to first study vaccination.
- Any known allergies to products contained in the investigational product.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NVX-CoV2373Also: Monovalent SARS-CoV-2 rS vaccine premixed with Matrix-M adjuvantAlternating intramuscular (IM) (deltoid) injections of monovalent prototype vaccine premixed with Matrix-M™ adjuvant (0.5 mL) given either as 2 doses (one on Day 0 and one on Day 21 or Day 70) and an injection of placebo (0.5mL) on Day 21 or Day 70, or 3 doses (Day 0, Day 21, and Day 70). | Biological | Group 1 PLWH, Group 2 PLWH, Group 3 PLWH, Group 4 HIV-Negative Participants, Group 5 HIV-Negative Participants |
Primary outcome
Number of PLWH with unsolicited adverse events (AEs)
Time frame: Day 84
Number of PLWH with unsolicited AEs stratified by level of control of HIV infection.
Number of HIV-Negative participants with unsolicited AEs
Time frame: Day 84
Number of HIV-Negative participants with unsolicited AEs.
Number of PLWH with unsolicited AEs
Time frame: Day 120
Number of PLWH with unsolicited AEs stratified by level of control of HIV infection.
Number of PLWH with unsolicited AEs
Time frame: Day 180
Number of PLWH with unsolicited AEs stratified by level of control of HIV infection.
Number of HIV-Negative participants with unsolicited AEs
Time frame: Day 120
Number of HIV-Negative participants with unsolicited AEs.
Number of HIV-Negative participants with unsolicited AEs
Time frame: Day 180
Number of HIV-Negative participants with unsolicited AEs.
Number of PLWH with solicited systemic AEs
Time frame: Day 0
Number of PLWH with solicited systemic AEs for 7 days following each vaccination stratified by baseline severity of disease as determined by the level of control of HIV infection into well-controlled and less-well-controlled treatment groups.
Number of PLWH with solicited systemic AEs
Time frame: Day 21
Number of PLWH with solicited systemic AEs for 7 days following each vaccination stratified by baseline severity of disease as determined by the level of control of HIV infection into well-controlled and less-well-controlled treatment groups.
Number of PLWH with solicited systemic AEs
Time frame: Day 70
Number of PLWH with solicited systemic AEs for 7 days following each vaccination stratified by baseline severity of disease as determined by the level of control of HIV infection into well-controlled and less-well-controlled treatment groups.
Number of HIV-Negative participants with solicited systemic AEs
Time frame: Day 0
Number of HIV-Negative participants with solicited systemic AEs for 7 days following each vaccination.
Number of HIV-Negative participants with solicited systemic AEs
Time frame: Day 21
Number of HIV-Negative participants with solicited systemic AEs for 7 days following each vaccination.
Number of HIV-Negative participants with solicited systemic AEs
Time frame: Day 70
Number of HIV-Negative participants with solicited systemic AEs for 7 days following each vaccination.
Number of PLWH with solicited local AEs
Time frame: Day 0
Number of PLWH with solicited local AEs for 7 days following each vaccination stratified by baseline severity of disease as determined by the level of control of HIV infection into well-controlled and less-well-controlled treatment groups.
Number of PLWH with solicited local AEs
Time frame: Day 21
Number of PLWH with solicited local AEs for 7 days following each vaccination stratified by baseline severity of disease as determined by the level of control of HIV infection into well-controlled and less-well-controlled treatment groups.
Number of PLWH with solicited local AEs
Time frame: Day 70
Number of PLWH with solicited local AEs for 7 days following each vaccination stratified by baseline severity of disease as determined by the level of control of HIV infection into well-controlled and less-well-controlled treatment groups.
Number of HIV-Negative participants with solicited local AEs
Time frame: Day 0
Number of HIV-Negative participants with solicited local AEs for 7 days following each vaccination.
Number of HIV-Negative participants with solicited local AEs
Time frame: Day 21
Number of HIV-Negative participants with solicited local AEs for 7 days following each vaccination.
Number of HIV-Negative participants with solicited local AEs
Time frame: Day 70
Number of HIV-Negative participants with solicited local AEs for 7 days following each vaccination.
Serum Immunoglobulin (IgG) antibody levels expressed as geometric mean enzyme-linked immunosorbent assay units (GMEU)
Time frame: Day 21
Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as GMEUs in PLWH stratified by level of control of HIV infection.
Serum Immunoglobulin (IgG) antibody levels expressed as geometric mean enzyme-linked immunosorbent assay units (GMEU)
Time frame: Day 35
Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as GMEUs in PLWH stratified by level of control of HIV infection.
Serum Immunoglobulin (IgG) antibody levels expressed as geometric mean enzyme-linked immunosorbent assay units (GMEU)
Time frame: Day 70
Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as GMEUs in PLWH stratified by level of control of HIV infection.
Serum Immunoglobulin (IgG) antibody levels expressed as geometric mean enzyme-linked immunosorbent assay units (GMEU)
Time frame: Day 84
Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as GMEUs in PLWH stratified by level of control of HIV infection.
Serum IgG antibody levels expressed as geometric mean fold rise (GMFR)
Time frame: Day 21
Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as GMFRs in PLWH stratified by level of control of HIV infection.
Serum IgG antibody levels expressed as geometric mean fold rise (GMFR)
Time frame: Day 35
Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as GMFRs in PLWH stratified by level of control of HIV infection.
Serum IgG antibody levels expressed as geometric mean fold rise (GMFR)
Time frame: Day 70
Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as GMFRs in PLWH stratified by level of control of HIV infection.
Serum IgG antibody levels expressed as geometric mean fold rise (GMFR)
Time frame: Day 84
Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as GMFRs in PLWH stratified by level of control of HIV infection.
Serum IgG antibody levels expressed as seroconversion rate (SCR)
Time frame: Day 21
Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as SCRs in PLWH stratified by level of control of HIV infection.
Serum IgG antibody levels expressed as seroconversion rate (SCR)
Time frame: Day 35
Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as SCRs in PLWH stratified by level of control of HIV infection.
Serum IgG antibody levels expressed as seroconversion rate (SCR)
Time frame: Day 70
Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as SCRs in PLWH stratified by level of control of HIV infection.
Serum IgG antibody levels expressed as seroconversion rate (SCR)
Time frame: Day 84
Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as SCRs in PLWH stratified by level of control of HIV infection.
Human angiotensin-converting enzyme 2 (hACE2) receptor binding inhibition assay expressed as geometric mean titer (GMT)
Time frame: Day 21
Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as GMT in PLWH stratified by level of control of HIV infection.
Human angiotensin-converting enzyme 2 (hACE2) receptor binding inhibition assay expressed as geometric mean titer (GMT)
Time frame: Day 35
Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as GMT in PLWH stratified by level of control of HIV infection.
Human angiotensin-converting enzyme 2 (hACE2) receptor binding inhibition assay expressed as geometric mean titer (GMT)
Time frame: Day 70
Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as GMT in PLWH stratified by level of control of HIV infection.
Human angiotensin-converting enzyme 2 (hACE2) receptor binding inhibition assay expressed as geometric mean titer (GMT)
Time frame: Day 84
Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as GMT in PLWH stratified by level of control of HIV infection.
hACE2 receptor binding inhibition assay expressed as GMFR
Time frame: Day 21
Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as GMFR in PLWH stratified by level of control of HIV infection.
hACE2 receptor binding inhibition assay expressed as GMFR
Time frame: Day 35
Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as GMFR in PLWH stratified by level of control of HIV infection.
hACE2 receptor binding inhibition assay expressed as GMFR
Time frame: Day 70
Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as GMFR in PLWH stratified by level of control of HIV infection.
hACE2 receptor binding inhibition assay expressed as GMFR
Time frame: Day 84
Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as GMFR in PLWH stratified by level of control of HIV infection.
hACE2 receptor binding inhibition assay expressed as SCR
Time frame: Day 21
Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as SCR in PLWH stratified by level of control of HIV infection.
hACE2 receptor binding inhibition assay expressed as SCR
Time frame: Day 35
Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as SCR in PLWH stratified by level of control of HIV infection.
hACE2 receptor binding inhibition assay expressed as SCR
Time frame: Day 70
Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as SCR in PLWH stratified by level of control of HIV infection.
hACE2 receptor binding inhibition assay expressed as SCR
Time frame: Day 84
Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as SCR in PLWH stratified by level of control of HIV infection.
Neutralizing antibody activity expressed as GMT
Time frame: Day 35
Titers of neutralizing antibody to the prototype virus expressed as GMT in PLWH stratified by level of control of HIV infection.
Neutralizing antibody activity expressed as GMT
Time frame: Day 84
Titers of neutralizing antibody to the prototype virus expressed as GMT in PLWH stratified by level of control of HIV infection.
Neutralizing antibody activity expressed as SCR
Time frame: Day 35
Titers of neutralizing antibody to the prototype virus expressed as SCR in PLWH stratified by level of control of HIV infection.
Neutralizing antibody activity expressed as SCR
Time frame: Day 84
Titers of neutralizing antibody to the prototype virus expressed as SCR in PLWH stratified by level of control of HIV infection.
Neutralizing antibody activity expressed as GMFR
Time frame: Day 35
Titers of neutralizing antibodies to the prototype virus expressed as GMFR in PLWH stratified by level of control of HIV infection.
Neutralizing antibody activity expressed as GMFR
Time frame: Day 84
Titers of neutralizing antibodies to the prototype virus expressed as GMFR in PLWH stratified by level of control of HIV infection.
12 secondary outcomes
Serum IgG antibody levels expressed as GMEU
Time frame: Day 21
Serum IgG antibody levels expressed as GMEU
Time frame: Day 35
Serum IgG antibody levels expressed as GMEU
Time frame: Day 70
Serum IgG antibody levels expressed as GMEU
Time frame: Day 84
Serum IgG antibody levels expressed as GMFR
Time frame: Day 21
Serum IgG antibody levels expressed as GMFR
Time frame: Day 35
Serum IgG antibody levels expressed as GMFR
Time frame: Day 70
Serum IgG antibody levels expressed as GMFR
Time frame: Day 84
Serum IgG antibody levels expressed as SCR
Time frame: Day 21
Serum IgG antibody levels expressed as SCR
Time frame: Day 35
Serum IgG antibody levels expressed as SCR
Time frame: Day 70
Serum IgG antibody levels expressed as SCR
Time frame: Day 84
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Development study director
Novavax
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NVX-CoV2373 in people with SARS-CoV-2 Infection, run by Novavax at 7 sites in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of PLWH with unsolicited adverse events (AEs) (time frame: Day 84). The study lists 48 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.