Phase I study of a candidate vaccine based on recombinant HIV-1 gp160 (MN/LAI) administered by the mucosal route to HIV-seronegative volunteers: the ANRS VAC14 study.
One goal of HIV vaccination is to achieve high mucosal levels of specific secretory IgA (SIgA). In order to elicit specific SIgA antibodies against human immunodeficiency virus type-1 (HIV-1), a vaccine must be administered by the mucosal route, to the nasal or vaginal mucosa for example. We report here the results of the first phase I, randomized, open-label trial designed to assess the mucosal tolerability and immunogenicity of a candidate vaccine (recombinant protein HIV-1 gp160MN/LAI with or without DC-Chol adjuvant) administered by the nasal or vaginal route. Thirty-four female volunteers with a mean age of 46 years were vaccinated. There were 465 adverse events, of which 65 were considered related to the vaccine. No severe adverse events were related to the vaccine, and no difference in terms of tolerability was observed between the sites of vaccination or between the vaccine formulations. None of the volunteers reported that study participation affected their intimate or broader social relationships. No anti-gp160 activity was found between week 4 and week 48 in serum, saliva, or cervicovaginal and nasal secretions. These results show that a mucosal HIV vaccine can be well tolerated when administered by the nasal or vaginal route.
Pialoux
Gilles
G
APHP, Hôpital Tenon, 4 rue de la Chine, Paris Cedex 20, France. gilles.pialoux@tnn.aphp.fr
Hocini
Hakim
H
Pérusat
Sophie
S
Silberman
Benjamin
B
Salmon-Ceron
Dominique
D
Slama
Laurence
L
Journot
Valérie
V
Mathieu
Emmanuelle
E
Gaillard
Christophe
C
Petitprez
Karine
K
Launay
Odile
O
Chêne
Geneviève
G
D016915:AIDS Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D000276:Adjuvants, Immunologic / Q000008:administration & dosage; D000281:Administration, Intranasal; D000282:Administration, Intravaginal; D000328:Adult; D002584:Cervix Uteri / Q000276:immunology; D002784:Cholesterol / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D015483:HIV Antibodies / Q000032:analysis / Q000097:blood; D019302:HIV Envelope Protein gp160 / Q000235:genetics / Q000276:immunology*; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D007070:Immunoglobulin A / Q000032:analysis / Q000097:blood; D008875:Middle Aged; D009297:Nasal Mucosa / Q000276:immunology; D011994:Recombinant Proteins / Q000235:genetics / Q000276:immunology; D012463:Saliva / Q000276:immunology
D016915:AIDS Vaccines; D000276:Adjuvants, Immunologic; D015483:HIV Antibodies; D019302:HIV Envelope Protein gp160; D007070:Immunoglobulin A; D011994:Recombinant Proteins; C514797:gp160 protein, Human immunodeficiency virus 1; C070648:3-(N-(N',N'-dimethylaminoethane)carbamoyl)cholesterol; D002784:Cholesterol