NCT03122223

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	ALVAC-HIV (vCP2438)	expresses the gene products 96ZM651 gp120 (clade C strain) linked to the sequences encoding the HIV-1 transmembrane anchor (TM) sequence of gp41 (28 amino acids clade B LAI strain) and Gag and Pro (clade B LAI strain). It is formulated as a lyophilized vaccine for injection at a viral titer greater than or equal to 1 × 10\^6 cell culture infectious dose (CCID)50 and less than 1 × 10\^8 CCID50 (nominal dose of 10\^7 CCID50) and is reconstituted with 1 mL of sterile sodium chloride solution (NaCl 0.4%), administered IM as a single 1 mL dose.
BIOLOGICAL	Bivalent subtype C gp120/MF59	clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered IM as a single 0.5 mL dose.
BIOLOGICAL	Bivalent subtype C gp120/AS01(B)	clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 20 mcg or 100 mcg, mixed with AS01B adjuvant, administered IM as a single 0.75 mL dose.
BIOLOGICAL	Placebo	Sodium Chloride for Injection, 0.9%, administered IM.

Timeline

• Start date: 2018-01-16
• Primary completion: 2020-07-30
• Completion: 2020-07-30
• First posted: 2017-04-20
• Last updated: 2023-03-14
• Results posted: 2021-01-08

Locations

12 sites across 4 countries: United States, Tanzania, Zambia, Zimbabwe

Regulatory

• FDA-regulated drug study