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Evaluating the Safety and Immunogenicity of ALVAC-HIV and MF59®- or AS01B-adjuvanted Bivalent Subtype C gp120 in Healthy, HIV-uninfected Adult Participants — HVTN 120  

HIV Infections Clinical Trial

Official title:
A Phase 1/2a Clinical Trial to Evaluate the Safety and Immunogenicity of ALVAC-HIV (vCP2438) and of MF59®- or AS01B-adjuvanted Clade C Env Protein, in Healthy, HIV-uninfected Adult Participants

Clinical Trial Summary

A phase 1/2a clinical trial to evaluate the safety and immunogenicity of ALVAC-HIV (vCP2438) and of MF59®- or AS01B-adjuvanted clade C Env protein, in healthy, HIV-uninfected adult participants

Clinical Trial Description

The primary objective of this study is to evaluate the safety and tolerability of ALVAC-HIV and bivalent gp120 protein/MF59 or bivalent gp120 protein/AS01(B). This study will also compare HIV-specific CD4+ T-cell response rates at the Month 6.5 timepoint (2 weeks after the fourth vaccination) of ALVAC-HIV and bivalent gp120 protein/MF59 to each of the bivalent gp120 protein/AS01(B) vaccine regimens. Additionally, this study will compare HIV-specific Env-gp120 binding antibody response magnitudes at the Month 12 timepoint (6 months after the fourth vaccination) of ALVAC-HIV and bivalent gp120 protein/MF59 to each of the bivalent gp120 protein/AS01(B) vaccine regimens. The study will enroll 160 healthy, HIV-uninfected volunteers aged 18 to 40 years. Groups 1 to 3 will consist of a total of 150 participants who will receive the vaccines at Months 0, 1, 3, and 6, while 10 participants in Group 4 will receive placebos at Months 0, 1, 3, 6. Study visits will include a physical examination, an interview and/or questionnaire, HIV testing and HIV risk-reduction counseling, and urine and blood collection. Participants may optionally choose to provide rectal fluid, cervical fluid, semen, and/or stool samples. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03122223
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Completed
Phase Phase 1/Phase 2
Start date January 16, 2018
Completion date July 30, 2020
View Details
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