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COVID-19Phase 2AUR1-8-341NCT05515042

Phase 2a Trial to Evaluate Safety and Immunogenicity of COVID-19 Vaccine Strategies in HIV-infected/Uninfected Adults.

A Phase 2 study testing Ad26.COV2.S (VAC31518, JNJ-78436735) Vaccine, SARS-CoV-2 rS (CovovaxTM), BNT162b2 (Pfizer) in people with COVID-19, run by The Aurum Institute NPC at 5 sites in South Africa.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a multicenter, randomized, observer blind clinical trial. A total of 750 evaluable HIV-infected (660) and HIV-uninfected (90) adult participants meeting all entry criteria (all inclusion and no exclusion criteria) will be enrolled in 3 treatment strategies in 3 participant groups dependent on prior vaccination… Read more about this study

Who is it for?
Ages 18 to 100 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
Ad26.COV2.S (VAC31518, JNJ-78436735) Vaccine, SARS-CoV-2 rS (CovovaxTM), BNT162b2 (Pfizer)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
694 participants
Where
5 sitesSouth Africa
Study dates
25 Jul 2022to 31 Dec 2024
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 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • . Adult male or female aged 18 and above at the time of written informed consent
  • . Willing and able to give written informed consent
  • . HIV-infected persons on ART for at least three months prior to enrollment, or HIV-uninfected persons
  • . Able to provide evidence of completing a primary COVID-19 vaccination regimen with either a single dose of Ad26.COV2.S or two doses of BNT162b2 at least two months prior to enrolment, or HIV-infected with no prior COVID-19 vaccination and evidence of prior SAR-CoV-2 infection
  • . Residing in the vicinity of the clinical trial site and planning to remain in the area of the study for 12months
  • . Able and willing to participate for the duration of the study visits and follow-up
  • . Willing to provide verifiable identification (eg. Identity document, passport) at study entry and follow-up visits

Who cannot join

  • . Positive SARS-CoV-2 PCRor antigen detection test
  • . Persons with undocumented HIV status
  • . HIV-infected persons with CD4count <1 00 cells/mm3and/or Viral Load > 1000 copies/ml
  • . Known allergy or history of anaphylaxis or other serious adverse reactions to specific COVID-19 vaccine constituents
  • . History of capillary leak syndrome, thrombosis with thrombocytopenia syndrome (TTS), heparin-induced thrombocytopenia (HIT), history of any neurological disorders or seizures including Guillain-Barré syndrome, with the exception of febrile seizures during childhood
  • . Participants with acute illness (this does not include minor illnesses such as diarrhoea or mild upper respiratory tract infection) or body temperature ≥38.0ºC on Day 1 will be excluded from randomization at that time but may be rescheduled for randomization and/or vaccination at a later date.
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  • . Participants who cannot communicate reliably with the investigator
  • . Pregnant or breastfeeding
  • . Women of childbearing potential who are not on an effective long-acting contraceptive method for at least 21 days prior to enrollment (date of signed informed consent) and not intending to continue contraception for up to 9 months post first vaccination.(See Section 10.5.1 below)
  • . Prior administration of an investigational coronavirus vaccine (for example, SARS-CoV-2, SARS-CoV, Middle East Respiratory Syndrome [MERS-CoV] vaccine), except for participants of the Sisonke trial
  • . Prior administration of any SARS-CoV-2 vaccine boost
  • . Has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the Investigator's judgment
  • . History of harmful substance or alcohol use within the past 2 years. This exclusion does not apply to cannabis use.
  • . Receipt of:
  • . Systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to the day of randomization (for corticosteroids, ≥20 mg/day prednisone equivalent). Topical tacrolimus is allowed if not used within 14 days prior to the day of randomization. Inhaled, nasal, and topical steroids are allowed.
  • . Intravenous blood products (red cells, platelets, immunoglobulins, monoclonal antibodies specific for SARS-CoV-2) within 3 months prior to enrollment
  • . Experimental vaccine within the past 6 months before first vaccination
  • . Any inactivated vaccines received within 14 days prior to first vaccination or planned within 14 days of first vaccination, or live attenuated vaccines received with 30 days prior to the first vaccination or planned within 30 days of the first vaccination.
  • . Participated in an interventional clinical study within 28 days prior to the Screening Visit (Day 1) or plans to do so while participating in this study.
  • . Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

South Africa5 sites

  • The Aurum Institute: Gavin J Churchyard Legacy Centre

    Klerksdorp, North West, 2571

  • The Aurum Institute: Pretoria Clinical Research Centre

    Pretoria, Gauteng, 0087

  • The Aurum Institute: Rustenburg Clinical Research Centre

    Rustenburg, North West, 0299

  • The Aurum Institute: Tembisa Clinical Research Centre, Clinic 4

    Tembisa, Gauteng, 1632

  • The Aurum Institute: Tembisa Clinical Research Centre

    Tembisa, Gauteng, 1632

Other trials in South Africa

About this study

Official title: A Phase 2a Trial to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine Strategies in HIV-infected and HIV-uninfected Adults.

This is a multicenter, randomized, observer blind clinical trial. A total of 750 evaluable HIV-infected (660) and HIV-uninfected (90) adult participants meeting all entry criteria (all inclusion and no exclusion criteria) will be enrolled in 3 treatment strategies in 3 participant groups dependent on prior vaccination with a single dose Janssen (Group 1), 2 doses of Pfizer (Group 2) or no prior COVID-19 vaccination with evidence of prior SARS-CoV-2 infection (Group 3) .A total of 300 participants per group will be enrolled in Groups 1 and 2 (255 HIV-infected and 45 HIV-uninfected per group), and 150 HIV-infected, unvaccinated participants in Group 3. Each treatment regimen (Vaccine Arm: A, B or C) will evaluate 250 participants. Groups 1 and 2 will enrol 85 HIV-infected and 15 HIV-uninfected per vaccine arm.

Conditions
COVID-19
Being tested
Ad26.COV2.S (VAC31518, JNJ-78436735) Vaccine, SARS-CoV-2 rS (CovovaxTM), BNT162b2 (Pfizer)
Keywords
Vaccines
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ad26.COV2.S (VAC31518, JNJ-78436735) Vaccine, SARS-CoV-2 rS (CovovaxTM), BNT162b2 (Pfizer)Drug

    As included in arm/group descriptions

Study groups in NCT05515042
Study groupRoleWhat they receive
Ad26.COV2.S (VAC31518, JNJ-78436735) VaccineActive comparatorDescription: The Ad26.COV2.Sis a recombinant, replication-defective adenovirus type 26 (Ad26) vector vaccine encoding the SARS-CoV-2 spike (S) glycoprotein. Dose: The Ad26.COV2.S drug product (DP) is supplied as a single-dose or multi-dose suspension (target DP titer is 1×1011 virus particles [vp]/mL or 2×1011 vp/mL) for intramuscular (IM) injection. Dosage Form: Sterile liquid suspension for injection Colourless to slightly yellow, clear to very opalescent suspension (pH 6-6.4). Packaging: The vaccine will be provided as a multi-dose vial with 5 doses per vial with a total volume of 2.5ml. Administration: Vaccination (5x10^10 vp dose) is given as a 0.5mL intramuscular injection into the deltoid muscle in the upper arm.
Receives: Drug: Ad26.COV2.S (VAC31518, JNJ-78436735) Vaccine, SARS-CoV-2 rS (CovovaxTM), BNT162b2 (Pfizer)
SARS-CoV-2 rS (CovovaxTM)Active comparatorDescription - SARS-CoV-2 rS (CovovaxTM): is a recombinant protein nanoparticle vaccine constructed from the SARS-CoV-2 full-length spike (S) glycoprotein co-formulated with Matrix-M1 adjuvant. Dose: Each 0.5ml of SARS-CoV-2 rS consists of 5μg of a recombinant nanoparticle spike protein plus 50 μg of Matrix-M1 adjuvant. Dosage Form: Suspension for injection COVOVAX™ is colourless to slightly yellow, clear to mildly opalescent, free to practically free from visible particles. Packaging: The vaccine will be supplied as a multi-dose vial containing 10 doses per vial Administration: Vaccinations are given as a 0.5mL intramuscular injection into the deltoid muscle in the upper arm
Receives: Drug: Ad26.COV2.S (VAC31518, JNJ-78436735) Vaccine, SARS-CoV-2 rS (CovovaxTM), BNT162b2 (Pfizer)
BNT162b2 (Pfizer) (Comirnaty)Active comparatorDescription: is a nucleoside-modified messenger RNA encoding the viral spike (S) glycoprotein of SARS-CoV-2. Vaccinations 30mcg (0.3mL) will be given as an intramuscular injection into the deltoid muscle in the upper arm. Dose: Each dose (0.3 mL) contains 30 micrograms of COVID-19 mRNA Vaccine. Dosage Form: White to off-white frozen suspension for Intramuscular (IM) injection Packaging: This vaccine will be supplied as a multidose vial and must be diluted with 0.9% Sodium Chloride USP before use. Each vial (0.45 mL) contains 6 doses of 0.3 mL after dilution. Administration: Comirnaty should be administered intramuscularly after dilution. Each dose must contain 0.3 mL of vaccine. The preferred site is the deltoid muscle of the upper arm
Receives: Drug: Ad26.COV2.S (VAC31518, JNJ-78436735) Vaccine, SARS-CoV-2 rS (CovovaxTM), BNT162b2 (Pfizer)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Objective and Endpoint/Outcome 1:

    In HIV-infected persons, to determine whether each boost vaccine regimen adequately boosts humoral immune responses (D15), overall and by prior vaccine regimen. In this case humoral response refers to SARS CoV-2 spike RBD protein-specific binding antibody (bAb) IgG and SARS CoV-2-specific neutralizing antibody (nAb).

    Endpoint/Outcome 1:

    • Geometric mean value of SARS CoV-2 spike RBD protein-specific binding antibody (bAb) at baseline and D15, where bAb is measured from serum using an ELISA-based antibody binding assay to the SARS-CoV-2 RBD protein. The ELISA-based antibody binding assay to the SARS-CoV-2 RBD protein will be used to measure the serum bAb concentrations. The bAb concentrations will be derived from the half-maximal Effective Concentration (EC50) and the Area under the curve (AUC), and summarised as the Geometric mean value of bAb

    Measured: 14 Months

  2. Primary Objective and Endpoint/Outcome 2:

    In HIV-infected persons, to determine whether each boost vaccine regimen adequately boosts humoral immune responses (D15), overall and by prior vaccine regimen. In this case humoral response refers to SARS CoV-2 spike RBD protein-specific binding antibody (bAb) IgG and SARS CoV-2-specific neutralizing antibody (nAb).

    Endpoint/Outcome 2:

    • Geometric mean value of SARS CoV-2-specific neutralizing antibody (nAb) at baseline and D15 where nAb is measured from serum using a pseudovirus neutralizing assay. The SARS-CoV-2 VSV pseudotyped virus-based assay will be used measure the serum nAb concentrations. The nAb concentrations will be derived from Half-maximal inhibitory concentration (IC50), and summarised as the Geometric mean value of nAb

    Measured: 14 Months

Secondary outcomes (7)

  1. Secondary Objective 1 and Endpoint/Outcome 1:

    In HIV-infected persons, to compare between Vaccine Arms (A, B, or C) humoral immune responses post boost vaccination (Day 15 and Months 6 and 12), overall and stratified by primary vaccination regimen, duration since primary vaccination, and age group. In this case humoral response refers to SARS CoV-2 spike RBD protein-specific binding antibody (bAb) and SARS CoV-2-specific neutralizing antibody (nAb).

    Endpoint/Outcome 1:

    • The ELISA-based antibody binding assay to the SARS-CoV-2 RBD protein will be used to measure the serum bAb concentrations. Geometric mean value of SARS CoV-2 spike RBD protein-specific binding antibody (bAb) at Day 15 and Months 6 and 12 is determined from the half-maximal Effective Concentration (EC50) and the Area under the curve (AUC)

    Measured: 14 Months

  2. Secondary Objective 1 and Endpoint/Outcome 2:

    In HIV-infected persons, to compare between Vaccine Arms (A, B, or C) humoral immune responses post boost vaccination (Day 15 and Months 6 and 12), overall and stratified by primary vaccination regimen, duration since primary vaccination, and age group. In this case humoral response refers to SARS CoV-2 spike RBD protein-specific binding antibody (bAb) and SARS CoV-2-specific neutralizing antibody (nAb).

    Endpoint/Outcome 2:

    • The SARS-CoV-2 VSV pseudotyped virus-based assay will be used measure the serum nAb concentrations. Geometric mean value of SARS CoV-2-specific neutralizing antibody (nAb) at Day 15 and Months 6 and 12 as measured by the half-maximal inhibitory concentration (IC50)

    Measured: 14 Months

  3. Secondary Objective 2 and Endpoint/Outcome 1:

    In HIV-infected persons, to describe the safety of each COVID-19 boost vaccine regimen. In this study safety is measured by moderate or severe solicited local and systemic adverse event (AE), serious adverse events (SAEs), medically attended AEs (MAAEs), or adverse events of special interest (AESI)

    Endpoint/Outcome 1:

    • Solicited local and systemic adverse events (AEs) within 7 days after each vaccine dose. The proportion of participants with at least one moderate or severe solicited local and systemic adverse event (AE) within 7 days after each vaccine dose, presented by study arm

    Measured: 14 Months

  4. Secondary Objective 2 and Endpoint/Outcome 2:

    In HIV-infected persons, to describe the safety of each COVID-19 boost vaccine regimen. In this study safety is measured by moderate or severe solicited local and systemic adverse event (AE), serious adverse events (SAEs), medically attended AEs (MAAEs), or adverse events of special interest (AESI)

    Endpoint/Outcome 2:

    • Unsolicited AEs within 28 days after each vaccine dose. The proportion of participants with at least one unsolicited AE within 28 days after each vaccine dose presented by study arm and stratified per study group

    Measured: 14 Months

  5. Secondary Objective 2 and Endpoint/Outcome 3:

    In HIV-infected persons, to describe the safety of each COVID-19 boost vaccine regimen. In this study safety is measured by moderate or severe solicited local and systemic adverse event (AE), serious adverse events (SAEs), medically attended AEs (MAAEs), or adverse events of special interest (AESI)

    Endpoint/Outcome 3:

    • The frequency of Serious adverse events (SAEs), medically attended AEs (MAAEs), or adverse events of special interest (AESI) from the first vaccine dose for up to 12 months after the last vaccine dose, presented by study arm and stratified per study group

    Measured: 14 Months

  6. Secondary Objective 3 and Endpoint/Outcome 1:

    In HIV-infected persons, to compare between Vaccine Arms (A, B, or C) the cellular immunogenicity post boost (D15 and months six and twelve), overall and stratified by primary vaccination regimen, duration since primary vaccination and age group. In this study cellular immunogenicity is measured by SARS CoV-2 specific CD4+ and CD8+ T-cell responses using ELISpot and flow cytometry from peripheral blood mononuclear cells.

    Endpoint/Outcome 1:

    • The SARS CoV-2 specific T-cell responses will be measured by the IFN-gamma ELISpot assay. In this study the outcome measure for IFN-gamma ELISpot is Spot Forming Units per 10^6 cells.

    Measured: 14 Months

  7. Secondary Objective 3 and Endpoint/Outcome 2:

    In HIV-infected persons, to compare between Vaccine Arms (A, B, or C) the cellular immunogenicity post boost (D15 and months six and twelve), overall and stratified by primary vaccination regimen, duration since primary vaccination and age group. In this study cellular immunogenicity is measured by SARS CoV-2 specific CD4+ and CD8+ T-cell responses using ELISpot and flow cytometry from peripheral blood mononuclear cells.

    Endpoint/Outcome 2:

    • The SARS CoV-2 specific CD4+ and CD8+ T-cell response will be measured by flow cytometry. The outcome measure for flow cytometry is the percentage T cell responses for the following cytokines: IFN-γ, IL-2, TNF-α and Granzyme B

    Measured: 14 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2022
  2. Study start25 Jul 2022
  3. Primary completion30 Jun 2024
  4. Study completion31 Dec 2024 (estimated)

Resources

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
Model description
This is a multicenter, randomized, observer blind clinical trial. A total of 750 evaluable HIV-infected (660) and HIV-uninfected (90) adult participants meeting all entry criteria (all inclusion and no exclusion criteria) will be enrolled in 3 treatment strategies in 3 participant groups dependent on prior vaccination with a single dose Janssen (Group 1), 2 doses of Pfizer (Group 2) or no prior COVID-19 vaccination with evidence of prior SARS-CoV-2 infection (Group 3). A total of 300 participants per group will be enrolled in Groups 1 and 2 (255 HIV-infected and 45 HIV-uninfected per group), and 150 HIV-infected, unvaccinated participants in Group 3. Each treatment regimen (Vaccine Arm: A, B or C) will evaluate 250 participants. Groups 1 and 2 will enrol 85 HIV-infected and 15 HIV-uninfected per vaccine arm.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
694 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05515042
Sponsor's protocol ID
AUR1-8-341 CEPI
Other IDs
DOH-27-062022-4961
Acronym
AUR1-8-341
Status last verified
Jul 2024
First submitted
11 Jul 2022
Last updated
15 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The applicants are committed to the open science practice and will ensure rapid sharing of research results with scientific communities, policy makers and public of interest through peer-reviewed journal, national and international conferences. All publications will adopt open access principles based on the gold and green models. The study team will prepare a dissemination plan for study updates and results dissemination to high level stakeholders (IECs, Ministries of Health, NDR, government officials and international stakeholders). Study updates will be communicated to participants, CAB, study staff and other key stakeholders (trial networks, health advocates) timeously. The proposed trial will be registered at the Clinicaltrials.gov and South African Clinical Trials Register (SANCTR). Investigators will write and review the interim analysis and final analysis reports and publications.

Publications

  • Govender V, Reddy T, Maenetje P, Beattie T, Adonis T, Nielson T, Moodley J, Mdluli J, Bhoola A, Angelo S, Panchia R, Mngadi K, Innes C, Brumskine W, Mlotshwa M, Nhlangulela L, Ncube I, Moyo-Gwete T, Moore PL, Keeton RS, Burgers W, Kumar K, Garg N, Tripathi A, Sayed S, Matsimela K, Mchunu N, Wallis R, Edward VA, Churchyard GJ; COVID-19 Vaccine Strategies study group. Safety and immunogenicity of a single dose of Ad26.COV2.S, BNT162b2, or SARS-CoV-2-rS-protein-nanoparticle in previously vaccinated and unvaccinated adults living with and without HIV in South Africa: a phase 2a randomised, observer-blind trial. Lancet HIV. 2026 Mar;13(3):e163-e175. doi: 10.1016/S2352-3018(25)00275-9. Epub 2026 Feb 11.

    PubMed 41690324

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ad26.COV2.S (VAC31518, JNJ-78436735) Vaccine, SARS-CoV-2 rS (CovovaxTM), BNT162b2 (Pfizer) in people with COVID-19, run by The Aurum Institute NPC at 5 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 7 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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?

Results are not available in the source record.

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?

Primary Objective and Endpoint/Outcome 1: (time frame: 14 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05515042, which also lists 1 linked publication.

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 15 Jul 2024.

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AUR1-8-341 Clinical Trial NCT05515042 | AzTrials