HIV InfectionsPhase 1NCT01423825
Evaluating the Safety and Immune Response to an HIV Vaccine Boost Following the Administration of Two HIV Vaccines, in HIV-Uninfected, Healthy Adults (Study Extension to HVTN 073/SAAVI 102)
A Phase 1 study testing Sub C gp140 Vaccine, MF59C.1 Adjuvant and Sodium chloride in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in 2 countries.
Trial summary
This is an extension of the HVTN 073/SAAVI 102 study. This study will evaluate the safety and immune response to an HIV envelope protein vaccine boost in people who have previously received the SAAVI DNA-C2 and SAAVI MVA-C vaccines or placebo in the HVTN 073/SAAVI 102 study. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Sub C gp140 Vaccine, MF59C.1 Adjuvant and Sodium chloride
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Aug 2011to Jul 2013
- Phase
- Phase 1
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Hemoglobin greater than or equal to 11.0 g/dL
- White blood cell (WBC) count greater than 2,500 cells/mm^3
- Platelets greater than or equal to 125,000/mm^3
- Chemistry panel: alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase less than 1.25 times the institutional upper limit of normal; creatinine less than or equal to the institutional upper limit of normal
- Normal urine:
- Negative urine glucose, and
Show all 14Show fewer
- Negative or trace urine protein, and
- Negative or trace urine hemoglobin (if trace hemoglobin is present on dipstick, a microscopic urinalysis within institutional normal range)
- Able and willing to provide informed consent
- Negative HIV-1 and -2 blood test: Participants must have a negative HIV test result as specified by the HVTN Laboratory Program's in-study HIV diagnostic algorithm
- Participants who were born female: negative serum or urine beta human chorionic gonadotropin (beta-HCG) pregnancy test performed on the day of initial study extension vaccination prior to vaccination
- Reproductive status: A participant who was born female must agree to consistently use effective contraception from at least 21 days prior to enrollment through 90 days after the participant's final vaccination, for sexual activity that could lead to pregnancy. More information on this criterion can be found in the protocol.
- Participants who were born female must also agree not to seek pregnancy through alternative methods such as artificial insemination or in vitro fertilization until after the last scheduled protocol visit
- Receipt of scheduled injection at visit 11 in the HVTN 073/SAAVI 102 study
Who cannot join
- Participant meets criteria for delay or discontinuation of vaccination or termination from the study. More information on this criterion can be found in the protocol.
- Participant has an unresolved AE that is possibly, probably, or definitely related to the study product
- Any medical, psychiatric, or social condition, or occupational or other responsibility that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a participant's ability to give informed consent (e.g., a skin condition overlying a potential injection site, which could interfere with reactogenicity assessment)
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States2 sites
Brigham and Women's Hospital Vaccine CRS (BWH VCRS)
Boston, Massachusetts, 02115-6110
Fenway Health (FH) CRS
Boston, Massachusetts, 02215-4302
South Africa2 sites
Emavundleni CRS
Cape Town, Western Cape, 7750
Soweto HVTN CRS
Johannesburg, Gauteng, 1864
About this study
Official title: A Phase 1 Placebo-Controlled Study Extension to HVTN 073 / SAAVI 102, to Evaluate the Safety and Immunogenicity of Novartis Sub C gp140 Vaccine With MF59 Adjuvant, as a Boost Following SAAVI DNA-C2 Vaccine and SAAVI MVA-C Vaccine, in HIV Uninfected Healthy Adult Participants in South Africa and the United States
This is an extension of the HVTN 073/SAAVI 102 study. This study will evaluate the safety and immune response to an HIV envelope protein vaccine boost in people who have previously received the SAAVI DNA-C2 and SAAVI MVA-C vaccines or placebo in the HVTN 073/SAAVI 102 study.
Read the detailed description
The HVTN 073/SAAVI 102 study is evaluating the safety of two experimental HIV vaccines-SAAVI DNA-C2 and SAAVI MVA-C-given sequentially as a prime-boost regimen in healthy, HIV-uninfected adults. This is an extension of that study and will enroll people who participated in the HVTN 073/SAAVI 102 study. Previous studies have shown that a protein vaccine boost to an HIV vaccine may improve antibody responses. This study will evaluate the safety and immune response to an HIV envelope protein vaccine-the Sub C gp140 vaccine with MF59 adjuvant-in healthy, HIV-uninfected adults who have previously participated in the HVTN 073/SAAVI 102 study. Study researchers will explore whether the addition of a protein boost vaccine to the SAAVI DNA-C2 and SAAVI MVA-C vaccine regimen improves antibody response.
This study will enroll people who participated in the HVTN 073/SAAVI 102 study,regardless of whether they received vaccine or placebo. Participants will be randomly assigned to receive either the Sub C gp140 vaccine with MF59 adjuvant or a placebo injection during study visits at baseline and Month 3. At the baseline and Month 3 visits, participants will undergo a physical examination, HIV testing and counseling, pregnancy testing for female participants, interviews and questionnaires, risk reduction counseling, and blood collection (at the baseline visit only). They will then receive their assigned vaccine or placebo as one injection in their upper arm. Participants will remain in the clinic for 30 minutes after receiving the vaccination for observation and monitoring. For 3 days after the vaccination, participants will record any side effects in a symptom log and make contact daily with the study site staff.
Additional study visits will occur at Weeks 1 and 2, 1 and 2 weeks after the Month 3 visit, and Months 6 and 9. At these visits, select baseline study procedures will occur. At Month 15, study staff will contact participants for follow-up health monitoring. Participants will then complete any annual health contacts for the original HVTN 073/SAAVI 102 study.
- Conditions
- HIV Infections
- Being tested
- Sub C gp140 Vaccine, MF59C.1 Adjuvant, Sodium chloride
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sub C gp140 VaccineBiological
100 mcg of Sub C gp140 vaccine admixed with MF59C.1 adjuvant administered as one 0.5 mL injection intramuscularly (IM) in either deltoid
MF59C.1 AdjuvantBiological
MF59C.1 adjuvant admixed with 100 mcg of Sub C gp140 vaccine administered as one 0.5 mL injection intramuscularly (IM) in either deltoid. MF59C.1 adjuvant contains no biologicals.
Sodium chlorideOther
Sodium chloride as 0.5 mL IM injection in either deltoid to act as placebo
| Study group | Role | What they receive |
|---|---|---|
| Sub C gp140/MF59C.1 Vaccine | Experimental | Participants will receive Sub C gp140 vaccine (100 mcg) admixed with MF59C.1 adjuvant administered as one 0.5 mL injection intramuscularly (IM) in either deltoid at baseline and Month 3. Receives: Biological: Sub C gp140 Vaccine; Biological: MF59C.1 Adjuvant |
| Sodium chloride for injection | Placebo comparator | Participants will receive placebo injection administered as 0.5 mL IM in either deltoid at baseline and Month 3. Receives: Other: Sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety data, including signs and symptoms of local and systemic reactogenicity, laboratory measures of safety, adverse events (AEs), and AEs requiring expedited adverse event (EAE) reporting to DAIDS
Measured: Measured through Month 15
Secondary outcomes (2)
HIV-1-specific neutralizing and binding antibody assays at 2 weeks following vaccination with Novartis Sub C gp140 with MF59
Measured: Measured at Months 0.5, 3.5 and 9
Neutralizing antibody breadth against heterologous primary isolates
Measured: Measured at Months 0.5, 3.5 and 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Glenda Gray, Study chair, University of the Witswatersrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01423825
- Sponsor's protocol ID
- HVTN 073E/SAAVI 102
- Other IDs
- 11824
- Status last verified
- Oct 2021
- First submitted
- 24 Aug 2011
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rerks-Ngarm S, Pitisuttithum P, Nitayaphan S, Kaewkungwal J, Chiu J, Paris R, Premsri N, Namwat C, de Souza M, Adams E, Benenson M, Gurunathan S, Tartaglia J, McNeil JG, Francis DP, Stablein D, Birx DL, Chunsuttiwat S, Khamboonruang C, Thongcharoen P, Robb ML, Michael NL, Kunasol P, Kim JH; MOPH-TAVEG Investigators. Vaccination with ALVAC and AIDSVAX to prevent HIV-1 infection in Thailand. N Engl J Med. 2009 Dec 3;361(23):2209-20. doi: 10.1056/NEJMoa0908492. Epub 2009 Oct 20.
PubMed 19843557Evans TG, Keefer MC, Weinhold KJ, Wolff M, Montefiori D, Gorse GJ, Graham BS, McElrath MJ, Clements-Mann ML, Mulligan MJ, Fast P, Walker MC, Excler JL, Duliege AM, Tartaglia J. A canarypox vaccine expressing multiple human immunodeficiency virus type 1 genes given alone or with rgp120 elicits broad and durable CD8+ cytotoxic T lymphocyte responses in seronegative volunteers. J Infect Dis. 1999 Aug;180(2):290-8. doi: 10.1086/314895.
PubMed 10395842Srivastava IK, Kan E, Sun Y, Sharma VA, Cisto J, Burke B, Lian Y, Hilt S, Biron Z, Hartog K, Stamatatos L, Diaz-Avalos R, Cheng RH, Ulmer JB, Barnett SW. Comparative evaluation of trimeric envelope glycoproteins derived from subtype C and B HIV-1 R5 isolates. Virology. 2008 Mar 15;372(2):273-90. doi: 10.1016/j.virol.2007.10.022. Epub 2007 Dec 3.
PubMed 18061231Gray GE, Mayer KH, Elizaga ML, Bekker LG, Allen M, Morris L, Montefiori D, De Rosa SC, Sato A, Gu N, Tomaras GD, Tucker T, Barnett SW, Mkhize NN, Shen X, Downing K, Williamson C, Pensiero M, Corey L, Williamson AL. Subtype C gp140 Vaccine Boosts Immune Responses Primed by the South African AIDS Vaccine Initiative DNA-C2 and MVA-C HIV Vaccines after More than a 2-Year Gap. Clin Vaccine Immunol. 2016 Jun 6;23(6):496-506. doi: 10.1128/CVI.00717-15. Print 2016 Jun.
PubMed 27098021
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Placebo-Controlled Study Extension to HVTN 073 / SAAVI 102, to Evaluate the Safety and Immunogenicity of Novartis Sub C gp140 Vaccine With MF59 Adjuvant, as a Boost Following SAAVI DNA-C2 Vaccine and SAAVI MVA-C Vaccine, in HIV Uninfected Healthy Adult Participants in South Africa and the United States
- ClinicalTrials.gov ID
- NCT01423825
- Acronym / sponsor ID
- HVTN 073E/SAAVI 102
- Conditions
- HIV Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Aug 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 26 Aug 2011 (estimated)
- 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 an extension of the HVTN 073/SAAVI 102 study. This study will evaluate the safety and immune response to an HIV envelope protein vaccine boost in people who have previously received the SAAVI DNA-C2 and SAAVI MVA-C vaccines or placebo in the HVTN 073/SAAVI 102 study.
Detailed description
The HVTN 073/SAAVI 102 study is evaluating the safety of two experimental HIV vaccines-SAAVI DNA-C2 and SAAVI MVA-C-given sequentially as a prime-boost regimen in healthy, HIV-uninfected adults. This is an extension of that study and will enroll people who participated in the HVTN 073/SAAVI 102 study. Previous studies have shown that a protein vaccine boost to an HIV vaccine may improve antibody responses. This study will evaluate the safety and immune response to an HIV envelope protein vaccine-the Sub C gp140 vaccine with MF59 adjuvant-in healthy, HIV-uninfected adults who have previously participated in the HVTN 073/SAAVI 102 study. Study researchers will explore whether the addition of a protein boost vaccine to the SAAVI DNA-C2 and SAAVI MVA-C vaccine regimen improves antibody response.
This study will enroll people who participated in the HVTN 073/SAAVI 102 study,regardless of whether they received vaccine or placebo. Participants will be randomly assigned to receive either the Sub C gp140 vaccine with MF59 adjuvant or a placebo injection during study visits at baseline and Month 3. At the baseline and Month 3 visits, participants will undergo a physical examination, HIV testing and counseling, pregnancy testing for female participants, interviews and questionnaires, risk reduction counseling, and blood collection (at the baseline visit only). They will then receive their assigned vaccine or placebo as one injection in their upper arm. Participants will remain in the clinic for 30 minutes after receiving the vaccination for observation and monitoring. For 3 days after the vaccination, participants will record any side effects in a symptom log and make contact daily with the study site staff.
Additional study visits will occur at Weeks 1 and 2, 1 and 2 weeks after the Month 3 visit, and Months 6 and 9. At these visits, select baseline study procedures will occur. At Month 15, study staff will contact participants for follow-up health monitoring. Participants will then complete any annual health contacts for the original HVTN 073/SAAVI 102 study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sub C gp140/MF59C.1 Vaccine | Experimental | Biological: Sub C gp140 Vaccine, Biological: MF59C.1 AdjuvantParticipants will receive Sub C gp140 vaccine (100 mcg) admixed with MF59C.1 adjuvant administered as one 0.5 mL injection intramuscularly (IM) in either deltoid at baseline and Month 3. |
| Sodium chloride for injection | Placebo comparator | Other: Sodium chlorideParticipants will receive placebo injection administered as 0.5 mL IM in either deltoid at baseline and Month 3. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Hemoglobin greater than or equal to 11.0 g/dL
- White blood cell (WBC) count greater than 2,500 cells/mm^3
- Platelets greater than or equal to 125,000/mm^3
- Chemistry panel: alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase less than 1.25 times the institutional upper limit of normal; creatinine less than or equal to the institutional upper limit of normal
- Normal urine:
Key exclusion criteria (3 listed)
- Participant meets criteria for delay or discontinuation of vaccination or termination from the study. More information on this criterion can be found in the protocol.
- Participant has an unresolved AE that is possibly, probably, or definitely related to the study product
- Any medical, psychiatric, or social condition, or occupational or other responsibility that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a participant's ability to give informed consent (e.g., a skin condition overlying a potential injection site, which could interfere with reactogenicity assessment)
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 |
|---|---|---|
| Sub C gp140 Vaccine100 mcg of Sub C gp140 vaccine admixed with MF59C.1 adjuvant administered as one 0.5 mL injection intramuscularly (IM) in either deltoid | Biological | Sub C gp140/MF59C.1 Vaccine |
| MF59C.1 AdjuvantMF59C.1 adjuvant admixed with 100 mcg of Sub C gp140 vaccine administered as one 0.5 mL injection intramuscularly (IM) in either deltoid. MF59C.1 adjuvant contains no biologicals. | Biological | Sub C gp140/MF59C.1 Vaccine |
| Sodium chlorideSodium chloride as 0.5 mL IM injection in either deltoid to act as placebo | Other | Sodium chloride for injection |
Primary outcome
Safety data, including signs and symptoms of local and systemic reactogenicity, laboratory measures of safety, adverse events (AEs), and AEs requiring expedited adverse event (EAE) reporting to DAIDS
Time frame: Measured through Month 15
2 secondary outcomes
HIV-1-specific neutralizing and binding antibody assays at 2 weeks following vaccination with Novartis Sub C gp140 with MF59
Time frame: Measured at Months 0.5, 3.5 and 9
Neutralizing antibody breadth against heterologous primary isolates
Time frame: Measured at Months 0.5, 3.5 and 9
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 14 Oct 2021.
- Background: PubMed 19843557Rerks-Ngarm S, Pitisuttithum P, Nitayaphan S, Kaewkungwal J, Chiu J, Paris R, Premsri N, Namwat C, de Souza M, Adams E, Benenson M, Gurunathan S, Tartaglia J, McNeil JG, Francis DP, Stablein D, Birx DL, Chunsuttiwat S, Khamboonruang C, Thongcharoen P, Robb ML, Michael NL, Kunasol P, Kim JH; MOPH-TAVEG Investigators. Vaccination with ALVAC and AIDSVAX to prevent HIV-1 infection in Thailand. N Engl J Med. 2009 Dec 3;361(23):2209-20. doi: 10.1056/NEJMoa0908492. Epub 2009 Oct 20.
- Background: PubMed 10395842Evans TG, Keefer MC, Weinhold KJ, Wolff M, Montefiori D, Gorse GJ, Graham BS, McElrath MJ, Clements-Mann ML, Mulligan MJ, Fast P, Walker MC, Excler JL, Duliege AM, Tartaglia J. A canarypox vaccine expressing multiple human immunodeficiency virus type 1 genes given alone or with rgp120 elicits broad and durable CD8+ cytotoxic T lymphocyte responses in seronegative volunteers. J Infect Dis. 1999 Aug;180(2):290-8. doi: 10.1086/314895.
- Background: PubMed 18061231Srivastava IK, Kan E, Sun Y, Sharma VA, Cisto J, Burke B, Lian Y, Hilt S, Biron Z, Hartog K, Stamatatos L, Diaz-Avalos R, Cheng RH, Ulmer JB, Barnett SW. Comparative evaluation of trimeric envelope glycoproteins derived from subtype C and B HIV-1 R5 isolates. Virology. 2008 Mar 15;372(2):273-90. doi: 10.1016/j.virol.2007.10.022. Epub 2007 Dec 3.
- Derived from this study: PubMed 27098021Gray GE, Mayer KH, Elizaga ML, Bekker LG, Allen M, Morris L, Montefiori D, De Rosa SC, Sato A, Gu N, Tomaras GD, Tucker T, Barnett SW, Mkhize NN, Shen X, Downing K, Williamson C, Pensiero M, Corey L, Williamson AL. Subtype C gp140 Vaccine Boosts Immune Responses Primed by the South African AIDS Vaccine Initiative DNA-C2 and MVA-C HIV Vaccines after More than a 2-Year Gap. Clin Vaccine Immunol. 2016 Jun 6;23(6):496-506. doi: 10.1128/CVI.00717-15. Print 2016 Jun.
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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.
Glenda Gray study chair
University of the Witswatersrand
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sub C gp140 Vaccine, MF59C.1 Adjuvant and Sodium chloride in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in 2 countries.
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 14 inclusion and 3 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 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety data, including signs and symptoms of local and systemic reactogenicity, laboratory measures of safety, adverse events (AEs), and AEs requiring expedited adverse event (EAE) reporting to DAIDS (time frame: Measured through Month 15). 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 NCT01423825, which also lists 4 linked publications.
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 14 Oct 2021.