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Related post: Groups A and C meningococcal polysaccharide vaccines have been licensed as a result of efficacy studies in adults and older children. The group A Himalaya Rumalaya vaccine has been shown to be effective in children down to three months of age in an efficacy trial in Finland sponsored by the NIAID. Group C meningogoccal poly- saccharide vaccine is poorly imnunogenic in very young children. A capsular 9-13 polysaccharide extracted from a variant group C strain has been prepared at Rockefeller University. This new material is of a different chemical structure than the licensed group C vaccine, but it is antigenically cross-reactive. Through the NIAID program, this variant C vaccine has been shown to be superior to the licensed material in adults and children over two years of Rumalaya Cream age. Studies in infants are under way at the present time. Group B meningococcal polysaccharide is non-anti genie in humans. A candidate protein vaccine, extracted from the outer membrane layer of the organism, has been developed by the Bureau of Biologics/FDA. Phase I safety and antigenicity tests in adults and older children show that these age groups do respond to the vaccine but the response is disappointing. Studies are beginning in infants, however, as there are reasons to believe that children may respond better than older individuals. A second vaccine, a combination of outer membrane protein and a high molecular weight group B polysaccharide, has also been developed by the BoB. Evaluation of this material in adults is beginning. There are a limited number of grants in the bacterial meningitis area. One grantee is beginning studies on the role of Rumalaya Tablets secretory IgA in the host's de- fense against meningococcal infections, and several grantees are Buy Rumalaya looking at the cell envelope proteins of H^. influenzae as possible infant immunogens. Program staff is encouraging all efforts toward the development of meningitis vaccines for use in infants in view of the fact that most of the pure poly- saccharides have been non-immunogenic under 18 months of age. Efforts are being made to encourage research either toward modifying vaccines or better understanding the infant immune system so that we can overcome the lack of response in this age group. Toward this goal, a Program Project Grant RFA was developed during the past year for the establishment of "Research Unit(s) for the Prevention of Infectious Diseases in Infants." These units would have concentrated on developing vaccines or procedures for protection of the infant. Unfortunately, because of fund limitations, no awards could be made; however, one ROl award to study the infant immune response to ]H. influenzae antigens was made in FY 1980 and thus will represent the initial effort of the Program in this direction. Rocky Mountain Spotted Fever : The presently licensed vaccine for RMSF is not considered effective and is no longer commercially available. A new, inactivated, whole-cell vaccine has been developed at the U.S. Army Medical Research Institute for Infectious Diseases (USAMRIID). Because of our mutual interest, the NIAID has assisted with support of phase I clinical trials of the vaccine in adults at the USAMRIID facilities at Fort Detrick. The vac- cine protects animals and is immunogenic in man; additional clinical studies are being planned by NIAID. To locate potential populations for future vac- cine trials, the NIAID has recently initiated two studies of the epidemiology of RMSF in North Carolina and Maryland. Another contract to further study the USAMRIID vaccine in a guinea pig model is making progress; guinea pig breeding to develop a strain with consistent susceptibility, production of purified antigens for comparison with vaccine antigens, and assessment of local vaccine effects are under way. 9-14 Pertussis : Pertussis is an area of considerable interest to program staff be- cause the currently licensed vaccine, while Himalaya Rumalaya Forte effective, is sometimes responsible for rather serious reactions. Considering the advances that have been made in the past 10-15 years in the development of subcellular Himalaya Rumalaya Gel bacterial vaccines, it would seem that the technology is such that an improved pertussis vaccine is feasible. There are currently two grants in this area in the Bacterial Vac- cines Program; one grantee has made considerable progress in defining the nu- tritional requirements for maintaining strains of Bordetella pertussis with stable antigenic mosaics, and is attempting isolation of components of the cell which may Rumalaya Forte be useful potential vaccines. A second grant awarded in this fiscal year will also concentrate on the examination of various cellular com- ponents for their role in pathogenesis and their potential as candidate new vaccine antigens. Viral Vaccines Program The viral vaccine program covers those areas where research should be stimu- lated toward the goal of an effective vaccine but that are not covered by the other specific programs of the Branch. As a result of several workshops, it became clear that an attenuated varicella vaccine developed in Japan showed promise and should be field tested in the U.S. A contract with NYU to evaluate the vaccine in inmunosuppressed children has been initiated. The first phase is Rumalaya Gel to calibrate the titer, reactogenicity and antigenicity of the candidate vaccine in adults prior to using it in children. The Institute alSo has a grant with the University of Texas for similar phase 1 studies. Because of the difficulty in working with varicella and the need to determine markers of attenuation, several related grantees are working in conjunction with this overall vaccine development attempt. The program is further interested in research on the antigenic structure and other characteristics of the herpes viruses in the hope of developing more effective vaccine candidates not only for varicella, but for herpes infections in general and genital herpes in particular. The Development and Applications Branch also supports five General Vaccine Evaluation Units that form the backbone of the Branch's efforts for the control of important disease problems. Through these groups, different pop- ulations, including all age groups, normal and "at risk," are available. These groups are utilized for the evaluation of all vaccines, viral and bacterial, and antivirals of interest to the Branch. During this past year these Units have been overtaxed and a backlog of work has developed. 9-15 EPIDEMIOLOGY AND BIOMETRY BRANCH The Branch expanded its activities in research with the initiation of several projects by Dr. Richard A. Kaslow and in extramural activities with the
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