The objective of this contract is to produce, scale-up, characterize and formulate reagent grade (GLP) and /or clinical grade (cGMP) HIV-1recombinant whole-killed vaccine products for animal and/or human trials. For clinical grade materials the manufacturer must perform all required vaccine lot characterization tests. The contractor must also work together with other contractors performing safety and immunogenicity testing of the vaccine product or producing FDA-required documentation in support of an IND.
| Dey, Antu K; Srivastava, Indresh K (2011) Novel adjuvants and delivery systems for enhancing immune responses induced by immunogens. Expert Rev Vaccines 10:227-51 |
| Caputo, Antonella; Brocca-Cofano, Egidio; Castaldello, Arianna et al. (2008) Characterization of immune responses elicited in mice by intranasal co-immunization with HIV-1 Tat, gp140 DeltaV2Env and/or SIV Gag proteins and the nontoxicogenic heat-labile Escherichia coli enterotoxin. Vaccine 26:1214-27 |
| Brave, Andreas; Hinkula, Jorma; Cafaro, Aurelio et al. (2007) Candidate HIV-1 gp140DeltaV2, Gag and Tat vaccines protect against experimental HIV-1/MuLV challenge. Vaccine 25:6882-90 |
| Srivastava, Indresh K; VanDorsten, Keating; Vojtech, Lucia et al. (2003) Changes in the immunogenic properties of soluble gp140 human immunodeficiency virus envelope constructs upon partial deletion of the second hypervariable region. J Virol 77:2310-20 |
