Safety, Tolerability, and Immunogenicity Study of Homologous Ad26 Mosaic Vector Vaccine Regimens or Heterologous Ad26 Mosaic and MVA Mosaic Vector Vaccine Regimens With Glycoprotein 140 (gp140) for Human Immunodeficiency Virus (HIV) Prevention
Condition: Healthy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to assess the safety and tolerability of various regimens
      containing adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV),
      Modified Vaccinia Ankara (MVA)-Mosaic, and/or HIV type 1 Clade C glycoprotein 140 drug
      product (gp140 DP) components and to compare envelope binding antibody responses between the
      different vaccine regimens.
    

Detailed description: 
      This is a multicenter (more than 1 hospital or medical school team work on a study),
      randomized (the study drug is assigned by chance), parallel group (each group of participants
      will be treated at the same time), placebo-controlled (study in which the experimental
      treatment or procedure is compared to a pretend treatment with no drug in it to test if the
      drug has a real effect), and double-blind (neither physician nor participant knows the
      treatment that the participant receives) study. All eligible participants will be randomly
      assigned to receive 1 of the 8 vaccine regimens. Participants will receive study vaccines
      (Ad26.Mos.HIV, MVA-Mosaic, gp140 DP, and placebo) 4 times as per assigned regimen. The study
      comprises a Screening Period (up to 4 weeks), a Vaccination Period (participants will be
      vaccinated at Baseline (Week 0), Week 12, Week 24 and Week 48), and a Follow-up Period (up to
      48 weeks). A long-term follow-up period (approximately 2 years after Week 96) will continue
      for participants randomized to the regimen subsequently selected for future studies, based on
      analysis of Week 28 data. If Week 28 data are inconclusive, Week 52 data will be considered
      for regimen selection. If no clear decision can be made, the extended follow-up period could
      include participants from more than 1 group for assessing durability of immune responses.
      Participants' safety will be monitored throughout the study.
    

Intervention name(s): Ad26.Mos.HIV; MVA-Mosaic; gp140 DP Low-dose; gp140 DP High-dose; Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Drug
Intervention description(s): Recombinant replication-deficient Ad26 vectored vaccine and consists of 3 Ad26 vectors, one containing a mosaic insert of envelop (Env) sequence, and 2 vectors containing mosaic inserts of Gag and Pol sequences (Ad26.Mos.1.Env + Ad26.Mos1.Gag-Pol + Ad26.Mos2.Gag-Pol). Total dose is 5*10^10 viral particle per 0.5 milliliter (mL) injection administered intramuscularly.; Recombinant live attenuated MVA virus-vectored vaccine that has been genetically engineered to express 2 mosaic Gag, Pol, and Env sequences (Mosaic 1 and Mosaic 2). Total dose is 10^8 plaque-forming unit per 0.5 mL injection administered intramuscularly.; The gp140 DP vaccine containing 50 mcg of total protein, mixed with aluminum phosphate adjuvant (0.425 mg aluminum), per 0.5 mL injection administered intramuscularly.; The gp140 DP vaccine containing 250 mcg of total protein, mixed with aluminum phosphate adjuvant, per 0.5 mL injection administered intramuscularly.; Normal saline, 0.5 mL injection administered intramuscularly.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Healthy; Acquired Immuno-Deficiency Syndrome; Acquired Immunodeficiency Syndrome Virus; adenovirus serotype 26; Ad26.Mos.HIV; Modified Vaccinia Ankara; Glycoprotein; Adjuvant; Vaccine; Placebo