CompletedPhase 1/2

Safety and Immunogenicity of Clade C ALVAC and gp120 HIV Vaccine

Mozambique, South Africa132 participantsStarted 2017-06-19

Plain-language summary

The purpose of this study is to evaluate the safety and immune response to an HIV clade C vaccine and to an MF59- or alum-adjuvanted clade C Env protein in healthy, HIV-uninfected adults.

Who can participate

Age range18 Years – 40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age of 18 to 40 years
✓. Access to a participating HVTN CRS and willingness to be followed for the planned duration of the study
✓. Ability and willingness to provide informed consent
✓. Assessment of understanding: volunteer demonstrates understanding of this study; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly
✓. Agrees not to enroll in another study of an investigational research agent
✓. Good general health as shown by medical history, physical exam, and screening laboratory tests
✓. Willingness to receive HIV test results
✓. Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling.

Exclusion criteria

✕. Blood products received within 120 days before first vaccination
✕. Investigational research agents received within 30 days before first vaccination
✕. Body mass index (BMI) ≥ 40; or BMI ≥ 35 with 2 or more of the following: systolic blood pressure \> 140 mm Hg, diastolic blood pressure \> 90 mm Hg, current smoker, known hyperlipidemia
✕. Intent to participate in another study of an investigational research agent or any other study that requires non-HVTN HIV antibody testing during the planned duration of the HVTN 107 study
✕. Pregnant or breastfeeding
✕. HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 107 PSRT will determine eligibility on a case-by-case basis.
✕. Non-HIV experimental vaccine(s) received within the last 5 years in a prior vaccine trial. Exceptions may be made for vaccines that have subsequently undergone licensure in a volunteer's country of residence. For volunteers who have received control/placebo in an experimental vaccine trial, the HVTN 107 PSRT will determine eligibility on a case-by-case basis. For volunteers who have received an experimental vaccine(s) greater than 5 years ago, eligibility for enrollment will be determined by the HVTN 107 PSRT on a case-by-case basis.
✕. Live attenuated vaccines other than influenza vaccine received within 30 days before first vaccination or scheduled within 14 days after injection (eg, measles, mumps, and rubella \[MMR\]; oral polio vaccine \[OPV\]; varicella; yellow fever)

What they're measuring

Occurrence of Vaccine-induced Systemic IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 2

Timeframe: Measured at Month 6.5

Level of Vaccine-induced Systemic IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 2

Timeframe: Measured at Month 6.5

Occurrence of Vaccine-induced Serum IgA Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 3

Timeframe: Measured at Month 6.5

Level of Vaccine-induced Serum IgA Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 3

Timeframe: Measured at Month 6.5

Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness

Timeframe: Measured through Month Measured through 3 days after each vaccine dose at Months 0, 1, 3, 6, and 12

Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration

Timeframe: Measured through Month Measured through 3 days after each vaccine dose at Months 0, 1, 3, 6, and 12

Trial details

NCT IDNCT03284710

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2019-12-12

Results submitted2020-12-14

View on ClinicalTrials.gov More HIV Infections trials

Who can participate

Age range18 Years – 40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age of 18 to 40 years
✓. Access to a participating HVTN CRS and willingness to be followed for the planned duration of the study
✓. Ability and willingness to provide informed consent
✓. Assessment of understanding: volunteer demonstrates understanding of this study; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly
✓. Agrees not to enroll in another study of an investigational research agent
✓. Good general health as shown by medical history, physical exam, and screening laboratory tests
✓. Willingness to receive HIV test results
✓. Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling.

Exclusion criteria

✕. Blood products received within 120 days before first vaccination
✕. Investigational research agents received within 30 days before first vaccination
✕. Body mass index (BMI) ≥ 40; or BMI ≥ 35 with 2 or more of the following: systolic blood pressure \> 140 mm Hg, diastolic blood pressure \> 90 mm Hg, current smoker, known hyperlipidemia
✕. Intent to participate in another study of an investigational research agent or any other study that requires non-HVTN HIV antibody testing during the planned duration of the HVTN 107 study
✕. Pregnant or breastfeeding
✕. HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 107 PSRT will determine eligibility on a case-by-case basis.
✕. Non-HIV experimental vaccine(s) received within the last 5 years in a prior vaccine trial. Exceptions may be made for vaccines that have subsequently undergone licensure in a volunteer's country of residence. For volunteers who have received control/placebo in an experimental vaccine trial, the HVTN 107 PSRT will determine eligibility on a case-by-case basis. For volunteers who have received an experimental vaccine(s) greater than 5 years ago, eligibility for enrollment will be determined by the HVTN 107 PSRT on a case-by-case basis.
✕. Live attenuated vaccines other than influenza vaccine received within 30 days before first vaccination or scheduled within 14 days after injection (eg, measles, mumps, and rubella \[MMR\]; oral polio vaccine \[OPV\]; varicella; yellow fever)

What they're measuring

Occurrence of Vaccine-induced Systemic IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 2

Timeframe: Measured at Month 6.5

Level of Vaccine-induced Systemic IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 2

Timeframe: Measured at Month 6.5

Occurrence of Vaccine-induced Serum IgA Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 3

Timeframe: Measured at Month 6.5

Level of Vaccine-induced Serum IgA Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 3

Timeframe: Measured at Month 6.5

Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness

Timeframe: Measured through Month Measured through 3 days after each vaccine dose at Months 0, 1, 3, 6, and 12

Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration

Timeframe: Measured through Month Measured through 3 days after each vaccine dose at Months 0, 1, 3, 6, and 12