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Safety and Immunogenicity of Clade C ALVAC and gp120 HIV Vaccine | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Safety and Immunogenicity of Clade C ALVAC and gp120 HIV Vaccine

A Phase 1/2a Partially Double-blinded, Randomized Clinical Trial to Characterize the Safety and Immunogenicity of Clade C ALVAC-HIV (vCP2438) and Bivalent Subtype C gp120 Alone, With MF59 Adjuvant, and With Alum Adjuvant in Healthy, HIV-uninfected Adult Participants

NCT03284710•National Institute of Allergy and Infectious Diseases (NIAID)

View on ClinicalTrials.gov

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.

Detailed Description

This study will evaluate the safety, tolerability, and immunogenicity to vCP2438 (an HIV clade C vaccine) and to an unadjuvanted or MF59- or alum-adjuvanted bivalent clade C gp120 in healthy, HIV-uninfected adults. The study will enroll healthy, HIV-uninfected participants aged 18 to 40 years. Participants will be randomly assigned to one of 4 groups. \[describe further\] Study visits will include a physical examination, an interview and/or questionnaire, HIV testing and HIV risk-reduction counseling, and urine and blood collection. A subset of participants will provide rectal fluid, cervical fluid, semen, or stool samples.

Eligibility

Age

18 - 40 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•General and Demographic Criteria
•1. Age of 18 to 40 years
•2. Access to a participating HVTN CRS and willingness to be followed for the planned duration of the study
•3. Ability and willingness to provide informed consent
•4. 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
•5. Agrees not to enroll in another study of an investigational research agent
•6. Good general health as shown by medical history, physical exam, and screening laboratory tests
•HIV-Related Criteria:
•7. Willingness to receive HIV test results
•8. Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling.
+27 more criteria

Exclusion Criteria

•General
•1. Blood products received within 120 days before first vaccination
•2. Investigational research agents received within 30 days before first vaccination
•3. 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
•4. 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
•5. Pregnant or breastfeeding
•Vaccines and other Injections
•6. 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.
•7. 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.
•8. 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)
+36 more criteria

Locations (6)

Polana Canico Health Research and Training Center (CISPOC), National Institute of Health (INS) CRS

Maputo, Mozambique

Aurum Tembisa CRS

Johannesburg, Gauteng, South Africa

Soweto HVTN CRS

Johannesburg, Gauteng, South Africa

eThekwini CRS

Durban, KwaZulu-Natal, South Africa

Emavundleni CRS

Cape Town, Western Cape, South Africa

Seke South CRS

Chitungwiza, Mashonaland East Province, Zimbabwe

Key Dates

Start Date

June 19, 2017

Primary Completion Date

December 12, 2019

Completion Date

December 12, 2019

Last Updated

September 19, 2024

Enrollment

132

ACTUAL participants

Conditions

HIV Infections

Interventions

ALVAC-HIV (vCP2438)

BIOLOGICAL

Bivalent Subtype C gp120/MF59

BIOLOGICAL

Bivalent Subtype C gp120 admixed with Al(OH)3 Suspension

BIOLOGICAL

Bivalent Subtype C gp120

BIOLOGICAL

Skeletal Muscle Energetics and Fatiguability in Older Individuals

NCT04142047

HIVHIV Infections

View study

RECRUITINGPHASE3

A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1

NCT06694805

HIV Infections

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 19, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Immunogenicity of Clade C ALVAC and gp120 HIV Vaccine

Inclusion Criteria

Exclusion Criteria

Skeletal Muscle Energetics and Fatiguability in Older Individuals

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