THE JOUR~AL OF INFECTIOUS DISEASE. VOL. 136, SUPPLEMENT. DECEMBER 1977 © 1977 by the University of Chicago. All rights reserved.
B.
MONOVALENT VACCINES IN ADULTS
Immunogenicity and Reactogenicity of Influenza A/New Jersey /76 Virus Vaccines in Normal Adults Raphael Dolin, Thomas G. Wise, Mark H. Mazur, Carme1ita U. Tuazon, and Francis A. Ennis
From the Medical Virology Section, Laboratory of Clinical Investigation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, and the Division of Virology, Bureau of Biologics, Food and Drug Administration, Bethesda, Maryland; and the Department of Medicine, George Washington University School 0/ Medicine, Washington, D.C.
To evaluate the reactogenicity and antigenicity of influenza vaccines for potential use in the National Influenza Immunization Program [1], the National Institute of Allergy and Infectious Diseases (NIAID; Bethesda, Md.), in collaboration with the Bureau of Biologics (BOB; Bethesda, Md.), the Center for Disease Control (CDC; Atlanta, Ga.), and the Department of Defense (DOD; Washington, D.C.), organized a series of cooperative clinical trials to be carried out at multiple centers throughout the United States. The purpose of these trials was to investigate potential acute reactions to immunization and to define the serum HAl antibody responses in vaccinees. The vaccines were provided by four commercial manufacturers in the United States (see Materials and Methods) and included both We thank Dr. David Alling for assistance in the performance of statistical analyses. Please address requests for reprints to Dr. Raphael Dolin, Medical Virology Section, National Institute of AI· lergy and Infectious Diseases, National Institutes of Health. Bethesda, Maryland 20014.
split-product (disrupted) [2] and whole-virus (nondisrupted) [3] preparations. To determine the optimal dosage for immunization, vaccines were first evaluated at concentrations of 200, 400, and 800 chick cell-agglutinating (CCA) units [4] per dose. The selection of this dose range was based on the extensive previous experience with similar influenza vaccines, which suggested that administration of these doses to adults would result in low levels of reaction and a high rate of serum antibody production [5, 6]. The first of these trials, to be described below, was an investigation of the response to immunization with monovalent influenza A/New Jersey /76 vaccines in normal volunteers between 19 and 59 years of age at the National Institutes of Health (NIH; Bethesda, Md.) and George Washington U niversi ty School of Medicine (Washington, D.C.). Additional trials, employing identical protocols, were carried out subsequently at other centers and are reported elsewhere in this issue.
5435
Downloaded from http://jid.oxfordjournals.org/ at Indiana University Library on July 28, 2015
Inactivated influenza A/New Jersey /76 virus vaccines were administered intramuscularly to 199 normal adults, aged 19-59, in doses of 200, 400, or 800 chick cellagglutinating units in a double-blind, placebo-controlled trial. Systemic reactions (including fever) were uncommon, were mild, lasted
B.
MONOVALENT VACCINES IN ADULTS
Immunogenicity and Reactogenicity of Influenza A/New Jersey /76 Virus Vaccines in Normal Adults Raphael Dolin, Thomas G. Wise, Mark H. Mazur, Carme1ita U. Tuazon, and Francis A. Ennis
From the Medical Virology Section, Laboratory of Clinical Investigation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, and the Division of Virology, Bureau of Biologics, Food and Drug Administration, Bethesda, Maryland; and the Department of Medicine, George Washington University School 0/ Medicine, Washington, D.C.
To evaluate the reactogenicity and antigenicity of influenza vaccines for potential use in the National Influenza Immunization Program [1], the National Institute of Allergy and Infectious Diseases (NIAID; Bethesda, Md.), in collaboration with the Bureau of Biologics (BOB; Bethesda, Md.), the Center for Disease Control (CDC; Atlanta, Ga.), and the Department of Defense (DOD; Washington, D.C.), organized a series of cooperative clinical trials to be carried out at multiple centers throughout the United States. The purpose of these trials was to investigate potential acute reactions to immunization and to define the serum HAl antibody responses in vaccinees. The vaccines were provided by four commercial manufacturers in the United States (see Materials and Methods) and included both We thank Dr. David Alling for assistance in the performance of statistical analyses. Please address requests for reprints to Dr. Raphael Dolin, Medical Virology Section, National Institute of AI· lergy and Infectious Diseases, National Institutes of Health. Bethesda, Maryland 20014.
split-product (disrupted) [2] and whole-virus (nondisrupted) [3] preparations. To determine the optimal dosage for immunization, vaccines were first evaluated at concentrations of 200, 400, and 800 chick cell-agglutinating (CCA) units [4] per dose. The selection of this dose range was based on the extensive previous experience with similar influenza vaccines, which suggested that administration of these doses to adults would result in low levels of reaction and a high rate of serum antibody production [5, 6]. The first of these trials, to be described below, was an investigation of the response to immunization with monovalent influenza A/New Jersey /76 vaccines in normal volunteers between 19 and 59 years of age at the National Institutes of Health (NIH; Bethesda, Md.) and George Washington U niversi ty School of Medicine (Washington, D.C.). Additional trials, employing identical protocols, were carried out subsequently at other centers and are reported elsewhere in this issue.
5435
Downloaded from http://jid.oxfordjournals.org/ at Indiana University Library on July 28, 2015
Inactivated influenza A/New Jersey /76 virus vaccines were administered intramuscularly to 199 normal adults, aged 19-59, in doses of 200, 400, or 800 chick cellagglutinating units in a double-blind, placebo-controlled trial. Systemic reactions (including fever) were uncommon, were mild, lasted
