Eugene B. Buynak

Live attenuated varicella virus vaccine. Efficacy trial in healthy children.

We conducted a double-blind, placebo-controlled efficacy trial of the live attenuated Oka/Merck varicella vaccine among 956 children between the ages of 1 and 14 years, with a negative clinical history of varicella. Of the 914 children who were serologically confirmed to be susceptible to varicella, 468 received vaccine and 446 received placebo. The vaccine produced few clinical reactions and was well tolerated. There was no clinical evidence of viral spread from vaccinated children to sibling controls. Approximately eight weeks after vaccination, 94 per cent of the initially seronegative children who received vaccine had detectable antibody to varicella. During the nine-month surveillance period, 39 clinically diagnosed cases of varicella, 38 of which were confirmed by laboratory tests, occurred among study participants. All 39 cases occurred in placebo recipients; no child who received vaccine contracted varicella. The vaccine was 100 per cent efficacious in preventing varicella in this population of healthy children (P less than 10(-9).

Live, Attenuated Mumps-Virus Vaccine

MUMPS is a common childhood disease that may be severely and even permanently crippling when it involves the brain, testis, ovary, auditory nerves or pancreas. Adult males may be permanently steril...

Purified and inactivated human hepatitis B vaccine: progress report.

Developments leading to the preparation and testing for safety and potency of a highly purified inactivated preparation of hepatitis B surface antigen are descirbed. Protective efficacy studies in chimps of a lot of the inactivated hepatitis B vaccine are currently and suitable for clinical trials in man.

Clinical and Laboratory Studies of Combined Live Measles, Mumps, and Rubella Vaccines Using the RA 27/3 Rubella Virus

Abstract Eleven lots of combined bivalent and trivalent vaccines containing the measles (Moraten), mumps (Jeryl Lynn), and rubella (RA 2713) viruses gave satisfactory results in tests in initially seronegative children (measles, 493 children; mumps, 377; rubella, 586). There was no apparent suppression of antibody response against any of the viruses in the vaccines. The clinical reactions observed were mild and inconsequential. Substitution of the HPV 77-DE strain employed heretofore with the RA 27/3 is technically acceptable and offers the advantage of higher titer, slightly greater seroconversion rate, and more solid immunity against reinfection in nature.

Clinical and laboratory studies of live cytomegalovirus vaccine Ad-169.

Summary Live strain Ad-169 vaccine was prepared in human diploid cell strain WI-38 and studied clinically in 43 adult male priests and seminarians. All seronegative persons who were vaccinated developed antibody, and the immune adherence and neutralizing antibodies persisted at high levels for at least one year. Clinical reactions were minor consisting mainly of soreness, induration, and erythema at the injection site and mild systemic reaction including headache, chills, fatigue, myalgia, and fever in a few persons. It was not possible to recover virus from the peripheral leukocytes, urine, or throat of seronegative persons who were vaccinated. Susceptible persons who were in contact with the vaccinated persons failed both to excrete virus and to develop antibody indicating lack of contagious spread of the vaccine virus. Continuing investigations to measure the safety and efficacy of the vaccine seem highly justified in view of the importance of the virus in fetal damage, transfusion disease, and organ transplantation.

Stability on storage at various temperatures of live measles, mumps and rubella virus vaccines in new stabilizer.

Dried live measles, mumps and rubella virus vaccines prepared in a new stabilizing medium were tested for loss of potency, according to time, at a range of temperatures from −20°C to 54–56°C. All vaccines proved remarkably stable and predictive values for retention of adequate potency for periods of time at a range of temperatures are presented. The quality of the current vaccine should go far toward assuring potency under adverse conditions of handling in developed countries and in handling outside the cold chain in emerging parts of the world.

Persistence of antibody in human subjects for 7 to 10 years following administration of combined live attenuated measles, mumps, and rubella virus vaccines.

Abstract Antibody persistence was measured in children in the open community 10.5 years after combined measles-mumps-rubella (14 children), 9 years after measles-rubella (17 children), 10.5 years after mumps-rubella (9 children), and 7 years after measles-mumps (20 children) vaccines were given. There were increases, declines, and stationary titers among the children in the serum samples taken 6 weeks after vaccination compared with those taken at later time periods. This reflected a decline in antibody in some children and subclinical natural reinfection in others. Importantly, all the children still retained detectable antibody, indicating long-term persistence of immunity by vaccination with combined virus vaccines.

Development and Chimpanzee Testing of a Vaccine against Human Hepatitis B

Summary Highly purified hepatitis B virus surface antigen (Australia antigen) purified by physical and chemical procedures from infected human plasma was used to prepare hepatitis B vaccine. The purified antigen was treated with formalin and the vaccine was tested exhaustively for safety by ordinary procedures and additionally in marmosets (for live hepatitis A virus) and in chimpanzees (for live hepatitis B virus). The vaccine was highly potent, inducing antibody in guinea pigs, grivet monkeys, and chimpanzees given three doses of vaccine containing up to 20 μg of hepatitis B antigen per dose. A protective efficacy trial was carried out in chimpanzees that were given three doses of vaccine subcutaneously and then challenged intravenously with 1000 chimpanzee infectious doses of human hepatitis B virus. All of five unvaccinated control animals developed hepatitis B virus an-tigenemia following challenge and all of six vaccinated animals were protected, including one animal that had failed to develop detectable antibody following vaccination.

Use of Living Attenuated Measles-Virus Vaccine in Early Infancy

ENDERS and his associates1 2 3 4 have described the recovery of measles virus in human and animal-cell cultures and the propagation of the virus in embryonated hens eggs and in cultures of chick e...

Rubella Vaccination in Adult Females

Abstract In all but one of 35 adult susceptible females on a suitable pregnancy control regimen rubella antibody developed after vaccination with HPV-77 rubella virus propagated in cell cultures of duck embryo. In 20 of the 35 women signs and symptoms consistent with rubella, including rash, arthritis, arthralgia, lymphadenopathy, malaise, and anorexia, developed. The illness was generally mild and transient though knee aspiration and intraarticular administration of hydrocortisone were indicated in one case. Rubella virus was recovered from the aspirated synovial fluid of one woman with arthritis whose knees were aspirated. Two women were treated with oral methyl prednisolone for five days. The onset of rash was 12 days after vaccination, on the average, and the beginning of arthritis arthralgia was 16 days. Recovery was complete.