Safety and immunogenicity of REMUNE™ in HIV-infected Thai subjects

• Published in: Vaccine 1998, Vol.16 (2), p.142-149
• Main Authors: Limsuwan, Anuwat, Churdboonchart, Vina, Moss, Ronald B., Sirawaraporn, Worachart, Sutthent, Reungpung, Smutharaks, Buranaj, Glidden, David, Trauger, Richard, Theofan, Georgia, Carlo, Dennis
• Format: Article
• Language: English
• Subjects: Adult; AIDS Vaccines - immunology; AIDS Vaccines - therapeutic use; AIDS/HIV; Amino Acid Sequence; Antibiotics. Antiinfectious agents. Antiparasitic agents; Antiviral agents; Biological and medical sciences; CD4 Lymphocyte Count; clinical trial; Female; Fundamental and applied biological sciences. Psychology; HIV; HIV Infections - blood; HIV Infections - immunology; HIV Infections - prevention & control; HIV-1 - genetics; HIV-1 - immunology; HIV-1 immunogen; Humans; Immunization; immunogenicity; Male; Medical sciences; Microbiology; Molecular Sequence Data; Pharmacology. Drug treatments; REMUNE; RNA, Viral - blood; safety; Thailand; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies; Virology
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/S0264-410X(97)88327-2

The safety and immunogenicity of REMUNE™, an HIV-specific immune based therapy for HIV infection, was evaluated in a cohort of 30 HIV infected subjects in Thailand. This therapy utilizes a gp120 depleted inactivated virus (HZ 321), which exhibits a high degree of conservation with the core antigens of both type B′ and E strains of HIV, the predominant Thailand isolates. The treatment was well tolerated, with no serious adverse events reported over the course of the 4-month trial. Treatment in which four doses were administered with REMUNE™ appeared to boost HIV-specific immune responses, with approximately 75% of the treated subjects demonstrating an increase in either the repertoire or the intensity of the serological response to HIV as measured by Western blot. CD4%, viral load, and weight remained stable over the course of the 4-month study relative to baseline values. Viral subtyping of this cohort revealed a predominance of type ‘E’. These data suggest that REMUNE™ is safe and immunogenic in seropositive Thai subjects and suports further study of the therapeutic potential of REMUNE™ to treat HIV-1 infection.