202
Participants
Start Date
June 18, 2013
Primary Completion Date
February 2, 2015
Study Completion Date
February 2, 2015
ALVAC-HIV
Formulated as a lyophilized vaccine for injection and is reconstituted with 1.05 mL of sterile Sodium Chloride solution (0.4% NaCl) for a single 1 mL dose of \>1.0 x 106 CCID50/mL, to administer intramuscularly (IM).
AIDSVAX B/E
300 mcg of subtype B (MN) HIV gp120 glycoprotein and 300 mcg of subtype E (A244) HIV gp120 glycoprotein adsorbed onto 600 mcg of aluminum hydroxide gel adjuvant. Each vial contains 1.2 mL of sterile suspension, to administer 1 mL IM.
Placebo for ALVAC-HIV
A sterile, lyophilized product that consists of a mixture of virus stabilizer, and freeze drying medium and is reconstituted with 1.05 mL of sterile Sodium Chloride (0.4% NaCl) for a single 1 mL dose, to administer IM.
Placebo for AIDSVAX B/E
Sodium Chloride for Injection, 0.9% administered IM.
Hepatitis B vaccine
Each 1 mL dose contains 20 mcg of hepatitis B surface antigen (HBsAg) adsorbed onto 500 mcg aluminum as aluminum hydroxide, to administer IM.
Tetanus toxoid vaccine
The active ingredient is tetanus toxoid (≥ 40 I.U. / 0.5 mL) adsorbed on aluminium hydroxide dihydrate (600 mcg of aluminium), to administer IM.
Placebo for hepatitis B vaccine
Sodium Chloride for Injection, 0.9% administered IM.
Placebo for tetanus vaccine
Sodium Chloride for Injection, 0.9% administered IM.
Perinatal HIV Research Unit, Soweto
Aurum Institute for Health Research, Klerksdorp
Emavundleni Desmond Tutu HIV Centre CRS, Cape Town
HIV Vaccine Trials Network
NETWORK