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VRC-HIVADV014-00-VP is a recombinant adenoviral vector vaccine developed for HIV prevention. ## Composition and Design VRC-HIVADV014-00-VP is composed of four replication-defective, recombinant serotype 5 adenoviral vectors. Each vector expresses one of four HIV-1 antigens in a 3:1:1:1 ratio: - Clade B Gag/Pol polyproteins - Clade A Env glycoprotein - Clade B Env glycoprotein - Clade C Env glycoprotein The vaccine was designed with specific modifications to ensure safety and enhance immunogenicity. The adenoviral vectors were constructed using a GV11 adenoviral backbone with deletions of two essential regions (E1 and E4) as well as a partial E3 deletion, rendering the vaccine product replication deficient while providing increased transgene capacity. ## Development and Clinical Testing The vaccine was initially developed by the Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases. It has been studied both as a standalone vaccine and in prime-boost regimens with the DNA vaccine VRC-HIVDNA016-00-VP. In clinical trials, VRC-HIVADV014-00-VP was administered intramuscularly at dosages of either 10^10 or 10^11 particle units (PU). The vaccine has been evaluated in multiple Phase 1 and Phase 2 clinical trials across several countries including the United States, South Africa, Brazil, Jamaica, and Haiti. ## Immunogenicity and Safety In clinical trials, VRC-HIVADV014-00-VP appeared safe and was immunogenic, inducing both T-cell and antibody responses. When used as a boost following DNA vaccine priming, it demonstrated enhanced immunogenicity, particularly when the DNA vaccine was delivered using a needle-free Biojector device compared to needle and syringe administration. The vaccine has shown the ability to induce CD4+ T-cell responses and antibody responses against HIV Env antigens, which may be important factors in potential protective immunity. ## Development Status According to the search results, the highest development phase reached for this vaccine was Phase 2 for HIV infections, but development appears to have been discontinued. Clinical trials were conducted between 2005 and 2011 in various countries. The vaccine represents an important step in HIV vaccine development, though like many other HIV vaccine candidates, it has not progressed to approval for widespread use.
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