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Safety and Immunogenicity of a Randomized Phase 1 Prime-Boost Trial With ALVAC-HIV (vCP205) and Oligomeric Glycoprotein 160 From HIV-1 Strains MN and LAI-2 Adjuvanted in Alum or Polyphosphazene
- Source :
- Journal of Infectious Diseases. 213:1946-1954
- Publication Year :
- 2016
- Publisher :
- Oxford University Press (OUP), 2016.
-
Abstract
- Background Prime-boost regimens comprising ALVAC-HIV (prime) and human immunodeficiency virus type 1 (HIV) Env (boost) induce HIV-specific neutralizing antibody and cell-mediated immune responses, but the impact of boost schedule and adjuvant requires further definition. Methods A phase 1 trial was conducted. In part A (open label), 19 volunteers received oligomeric glycoprotein 160 from HIV strains MN and LAI-2 (ogp160 MN/LAI-2) with dose escalation (25, 50, 100 μg) and either polyphosphazene (pP) or alum adjuvant. In part B, 72 volunteers received either placebo (n=12) or recombinant canarypox virus expressing HIV antigens (ALVAC-HIV [vCP205]) with different doses and schedules of ogp160 MN/LAI-2 in pP or alum (n = 60). Results The vaccines were safe and well tolerated, with no vaccine-related serious adverse events. Anti-gp70 V1V2 antibody responses were detected in 17 of 19 part A volunteers (89%) and 10%-100% of part B volunteers. Use of a peripheral blood mononuclear cell-based assay revealed that US-1 primary isolate neutralization was induced in 2 of 19 recipients of ogp160 protein alone (10.5%) and 5 of 49 prime-boost volunteers (10.2%). Among ogp160 recipients, those who received pP were more likely than those who received alum to have serum that neutralized tier 2 viruses (12% vs 0%; P = .015). Conclusions Administration of ogp160 with pP induces primary isolate tier 2 neutralizing antibody responses in a small percentage of volunteers, demonstrating proof of concept and underscoring the importance of further optimization of prime-boost strategies for HIV infection prevention. Clinical trials registration NCT00004579.
- Subjects :
- Adult
Male
0301 basic medicine
Adolescent
HIV Antigens
Polymers
medicine.medical_treatment
HIV Infections
Canarypox virus
HIV Antibodies
complex mixtures
HIV Envelope Protein gp160
Young Adult
Major Articles and Brief Reports
03 medical and health sciences
chemistry.chemical_compound
Organophosphorus Compounds
0302 clinical medicine
Adjuvants, Immunologic
medicine
Humans
Immunology and Allergy
030212 general & internal medicine
Alum adjuvant
Primary isolate
Neutralizing antibody
AIDS Vaccines
biology
Alum
business.industry
Immunogenicity
virus diseases
Middle Aged
Antibodies, Neutralizing
Virology
030104 developmental biology
Infectious Diseases
chemistry
Immunology
HIV-1
Leukocytes, Mononuclear
biology.protein
Alum Compounds
Female
Immunization
business
Adjuvant
Subjects
Details
- ISSN :
- 15376613 and 00221899
- Volume :
- 213
- Database :
- OpenAIRE
- Journal :
- Journal of Infectious Diseases
- Accession number :
- edsair.doi.dedup.....9caa571a602b05db900fc3ce7efbcb51