0

The full content of Annals is available to subscribers

Subscribe/Learn More  >
Articles |

The Safety and Immunogenicity of a Human Immunodeficiency Virus Type 1 (HIV-1) Recombinant gp160 Candidate Vaccine in Humans

Raphael Dolin, MD; Barney S. Graham, MD; Stephen B. Greenberg, MD; Carol O. Tacket, MD; Robert B. Belshe, MD; Karen Midthun, MD; Mary Lou Clements, MD; Geoffrey J. Gorse, MD; Brian W. Horgan, PA; Robert L. Atmar, MD; David T. Karzon, MD; William Bonnez, MD; Bruce F. Fernie, ScD; David C. Montefiori, PhD; Donald M. Stablein, PhD; Gale E. Smith, PhD; Wayne C. Koff, PhD, NIAID AIDS Vaccine Clinical Trials Network
[+] Article and Author Information

Grant Support: By contracts (N01-AI-52577, N01-AI-72624, N01-AI-62528, N01-AI-52575, N01-AI-52576, N01-AI-72623, N01-AI-82500, N01-AI-62515) from the National Institutes of Health, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland.

Requests for Reprints: Raphael Dolin, MD, Infectious Disease Unit, Department of Medicine, University of Rochester Medical Center, 601 Elmwood Avenue, Box 689, Rochester, NY 14642.

Current Author Addresses: Drs. Dolin and Bonnez: University of Rochester Medical Center, 601 Elmwood Avenue, Box 689, Rochester, NY 14642.

Drs. Graham, Karzon, and Montefiori: Vanderbilt University, Medical Center North, Nashville, TN 37232.

Drs. Greenberg and Atmar: Baylor College of Medicine, One Baylor Plaza, Houston, TX 77030.

Dr. Tacket and Mr. Horgan: University of Maryland, Center for Vaccine Development, 10 South Pine Street, MSTF Building, Baltimore, MD 21201.

Drs. Belshe and Gorse: St. Louis University School of Medicine, 1402 South Grand Boulevard, St. Louis, MO 63104.

Drs. Midthun and Clements: Johns Hopkins University, Hampton House, 624 North Broadway, Baltimore, MD 21205.

Dr. Fernie: Division of Molecular Virology & Immunology, Georgetown University, 5640 Fishers Lane, Rockville, MD 20852.

Dr. Stablein: The Emmes Corporation, 11325 Seven Locks Road, Suite 214, Potomac, MD 20892.

Dr. Koff: AIDS Program, NIAID, Vaccine Research and Development Branch, 6003 Executive Boulevard, Rockville, MD 20892.


©1991 American College of PhysiciansAmerican College of Physicians


Ann Intern Med. 1991;114(2):119-127. doi:10.7326/0003-4819-114-2-119
Text Size: A A A

Objective: To evaluate the safety and immunogenicity of a human immunodeficiency virus type 1 (HIV-1) recombinant envelope glycoprotein (rgp160) candidate vaccine in humans.

Subjects: Healthy adults (72) who were seronegative for HIV-1 were randomly assigned to one of four groups.

Interventions: The subjects were randomly assigned to receive 40 or 80 µg of rgp160,10 µg of hepatitis B vaccine, or placebo in three doses (on days 0, 30, and 180), with an elective, nonblinded administration of a fourth dose on day 540.

Measurements and Main Results: Neither clinical nor laboratory toxicity was encountered during a follow-up period exceeding 21 months. No effect of immunization was noted on lymphocyte counts, mitogenic responses, or delayed-type hypersensitivity. Serum anti-body responses to HIV envelope proteins detected by Western blot were seen in 30 of 33 subjects (91%; 95% CI, 71% to 97%) receiving either 40- or 80-µg doses of rgp160 and were most commonly of weakly reactive intensity. Responses were first noted by Western blot after the second dose. They markedly increased in frequency after the third dose and declined over the next 12 to 18 months. The administration of a fourth dose resulted in homologous neutralizing activity in sera from 5 of 24 subjects (21%; CI, 7% to 37%) as well as in complement-mediated antibody-dependent enhancement in sera from 6 of 24 subjects (25%; CI, 10% to 42%). Antibody responses were detected by enzyme-linked immunosorbent assay (ELISA) less frequently than by Western blot, and these responses persisted for a shorter time.

Conclusions: The administration of rgp160 was well tolerated and safe, resulted in a high rate of antibody response by Western blot after the administration of the third and fourth doses, and generated serum neutralizing activity and complement-mediated antibody-dependent enhancement in some subjects after the fourth dose.

Figures

Tables

References

Letters

NOTE:
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).

Comments

Submit a Comment
Submit a Comment

Summary for Patients

Clinical Slide Sets

Terms of Use

The In the Clinic® slide sets are owned and copyrighted by the American College of Physicians (ACP). All text, graphics, trademarks, and other intellectual property incorporated into the slide sets remain the sole and exclusive property of the ACP. The slide sets may be used only by the person who downloads or purchases them and only for the purpose of presenting them during not-for-profit educational activities. Users may incorporate the entire slide set or selected individual slides into their own teaching presentations but may not alter the content of the slides in any way or remove the ACP copyright notice. Users may make print copies for use as hand-outs for the audience the user is personally addressing but may not otherwise reproduce or distribute the slides by any means or media, including but not limited to sending them as e-mail attachments, posting them on Internet or Intranet sites, publishing them in meeting proceedings, or making them available for sale or distribution in any unauthorized form, without the express written permission of the ACP. Unauthorized use of the In the Clinic slide sets will constitute copyright infringement.

Toolkit

Buy Now

to gain full access to the content and tools.

Want to Subscribe?

Learn more about subscription options

Advertisement
Related Articles
Related Point of Care
Topic Collections
PubMed Articles

Buy Now

to gain full access to the content and tools.

Want to Subscribe?

Learn more about subscription options

Forgot your password?
Enter your username and email address. We'll send you a reminder to the email address on record.
(Required)
(Required)