Le, Thong P., Coonan, Kevin M., Hedstrom, Richard C., Charoenvit, Yupin, Sedegah, Martha, Epstein, Judith E., Kumar, Sanjai, Wang, Ruobing, Doolan, Denise L., Maguire, Jason D., Parker, Suezanne E., Hobart, Peter, Norman, Jon, and Hoffman, Stephen L. (2000) Safety, tolerability and humoral immune responses after intramuscular administration of a malaria DNA vaccine to healthy adult volunteers. Vaccine, 18 (18). pp. 1893-1901.

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Abstract

DNA-based vaccines are considered to be potentially revolutionary due to their ease of production, low cost, long shelf life, lack of requirement for a cold chain and ability to induce good T-cell responses. Twenty healthy adult volunteers were enrolled in a Phase I safety and tolerability clinical study of a DNA vaccine encoding a malaria antigen. Volunteers received 3 intramuscular injections of one of four different dosages (20, 100, 500 and 2500 μg) of the Plasmodium falciparum circumsporozoite protein (PfCSP) plasmid DNA at monthly intervals and were followed for up to twelve months. Local reactogenicity and systemic symptoms were few and mild. There were no severe or serious adverse events, clinically significant biochemical or hematologic changes, or detectable anti-dsDNA antibodies. Despite induction of excellent CTL responses, intramuscular DNA vaccination via needle injection failed to induce detectable antigen-specific antibodies in any of the volunteers.

Item ID:	42770
Item Type:	Article (Research - C1)
ISSN:	1873-2518
Keywords:	DNA vaccine; malaria; clinical trial
Funders:	Naval Medical Research and Development Command (NMRDC), Federal Defense Laboratories Diversification Plan (FDLDP)
Date Deposited:	17 Mar 2016 03:54
FoR Codes:	11 MEDICAL AND HEALTH SCIENCES > 1107 Immunology > 110799 Immunology not elsewhere classified @ 100%
SEO Codes:	92 HEALTH > 9201 Clinical Health (Organs, Diseases and Abnormal Conditions) > 920109 Infectious Diseases @ 100%
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