Table 1.
Ongoing efficacy trials
Vaccine, phase, sponsor | Designation | Clade | n | Cohort | Start date | Immunogens | Comment |
---|---|---|---|---|---|---|---|
Canarypox/bivalent gp120, phase IIb/III, NIAID |
HVTN 702 | C | n = 5,400: 2,700 treated, 2,700 placebo | South African adults, age 18–35 |
Oct 2016 |
2 primes: ALVAC‐HIV (1 × 107 CCID50 (vCP2438) at weeks 0 and 4 3 boosts: ALVAC plus bivalent protein (100 µg TV1.C gp120 and 100 µg of 1086.C gp120) in MF59 at weeks 12, 24, and 52 |
Repeat of RV144 trial but with sequences for epidemic in South Africa. Will test for prevention of infection over 24 and possibly 36 months |
Ad26/gp140 phase IIb, Janssen vaccines and prevention B.V. |
HVTN 705 | All |
n = 2,600: 1,300 treated, 1,300 placebo |
Sub‐Saharan African women, age 18–35 | Nov 2017 |
2 primes: Tetravalent Ad26.Mos4.HIV (5 × 1010 viral particles) at weeks 0 and 12 2 boosts: Ad26.Mos4.HIV + Clade C gp140.HIV (250 µg) in aluminum phosphate at weeks 24 and 52 |
Testing for prevention of acquisition months 7–24 |
AMP phase IIb, NIAID |
HVTN 703, HPTN 081 |
All |
n = 1500: 500 for each of 2 treatment groups and 500 placebo |
Women from 7 countries in sub‐Saharan Africa, age 18–50 | May 2016 | Passive transfer: VRC01 bnAb transfused 10 times at 8‐week intervals at 20 or 30 mg/kg | Testing for prevention of acquisition by week 80, observation until week 92 |
AMP phase IIb, NIAID |
HVTN 704, HPTN 085 |
All |
n = 2,700: 900 for each of 2 treatment groups plus 900 placebo |
United States, Brazil, Peru, Switzerland MSM, transgender men, age 18–50 |
Apr 2016 | Passive transfer: VRC01 bnAb transfused 10 times at 8‐week intervals at 20 or 30 mg/kg | Testing for prevention of acquisition by week 80, observation until week 92 |
ALVAC, canarypox vector; AMP, antibody‐mediated protection; bnAb, broadly neutralizing antibody; CCID50, cell culture infectious dose for 50% of cultures; HIV, human immunodeficiency virus; HPTN, US National Institutes of Health Sponsored HIV Prevention Trials Network; HVTN, US National Institutes of Health sponsored HIV Vaccine Trials Network; MF59, a squalene‐based emulsion that is used as an adjuvant; MSM, men who have sex with men; NIAID, US National Institutes of Allergy and Infectious Diseases.