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Your search keyword '"Uzma N. Sarwar"' showing total 2 results
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2 results on '"Uzma N. Sarwar"'

1. Homologous boosting with adenoviral serotype 5 HIV vaccine (rAd5) vector can boost antibody responses despite preexisting vector-specific immunity in a randomized phase I clinical trial.

Author

Uzma N Sarwar, Laura Novik, Mary E Enama, Sarah A Plummer, Richard A Koup, Martha C Nason, Robert T Bailer, Adrian B McDermott, Mario Roederer, John R Mascola, Julie E Ledgerwood, Barney S Graham, and VRC 015 study team

Subjects
Medicine, Science
Abstract

Needle-free delivery improves the immunogenicity of DNA vaccines but is also associated with more local reactogenicity. Here we report the first comparison of Biojector and needle administration of a candidate rAd5 HIV vaccine.Thirty-one adults, 18-55 years, 20 naive and 11 prior rAd5 vaccine recipients were randomized to receive single rAd5 vaccine via needle or Biojector IM injection at 1010 PU in a Phase I open label clinical trial. Solicited reactogenicity was collected for 5 days; clinical safety and immunogenicity follow-up was continued for 24 weeks.Overall, injections by either method were well tolerated. There were no serious adverse events. Frequency of any local reactogenicity was 16/16 (100%) for Biojector compared to 11/15 (73%) for needle injections. There was no difference in HIV Env-specific antibody response between Biojector and needle delivery. Env-specific antibody responses were more than 10-fold higher in subjects receiving a booster dose of rAd5 vaccine than after a single dose delivered by either method regardless of interval between prime and boost.Biojector delivery did not improve antibody responses to the rAd5 vaccine compared to needle administration. Homologous boosting with rAd5 gene-based vectors can boost insert-specific antibody responses despite pre-existing vector-specific immunity.Clinicaltrials.gov NCT00709605 NCT00709605.

Published
2014
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2. DNA Priming for Seasonal Influenza Vaccine: A Phase 1b Double-Blind Randomized Clinical Trial

Author

Abbie R. Bellamy, Barney S. Graham, Shital M. Patel, Julie E. Ledgerwood, Galina Yamshchikov, Phyllis Renehan, Srilatha Edupuganti, Richard A. Koup, Thad Zajdowicz, Richard M. Schwartz, Brenda Larkin, Mary E. Enama, David I. Bernstein, Robert T. Bailer, Robert B. Belshe, Uzma N. Sarwar, and Vrc Study Team

Subjects
Adult, Male, Influenza vaccine, lcsh:Medicine, Biology, medicine.disease_cause, Injections, Intramuscular, DNA vaccination, Young Adult, Double-Blind Method, Immunity, Influenza, Human, Influenza A virus, medicine, Vaccines, DNA, Humans, lcsh:Science, Aged, Multidisciplinary, Hemagglutination assay, Influenza A Virus, H5N1 Subtype, lcsh:R, Middle Aged, Virology, Vaccination, Tolerability, Vaccines, Inactivated, Influenza Vaccines, Immunology, Inactivated vaccine, lcsh:Q, Female, Research Article
Abstract

Background The efficacy of current influenza vaccines is limited in vulnerable populations. DNA vaccines can be produced rapidly, and may offer a potential strategy to improve vaccine immunogenicity, indicated by studies with H5 influenza DNA vaccine prime followed by inactivated vaccine boost. Methods Four sites enrolled healthy adults, randomized to receive 2011/12 seasonal influenza DNA vaccine prime (n=65) or phosphate buffered saline (PBS) (n=66) administered intramuscularly with Biojector. All subjects received the 2012/13 seasonal inactivated influenza vaccine, trivalent (IIV3) 36 weeks after the priming injection. Vaccine safety and tolerability was the primary objective and measurement of antibody response by hemagglutination inhibition (HAI) was the secondary objective. Results The DNA vaccine prime-IIV3 boost regimen was safe and well tolerated. Significant differences in HAI responses between the DNA vaccine prime and the PBS prime groups were not detected in this study. Conclusion While DNA priming significantly improved the response to a conventional monovalent H5 vaccine in a previous study, it was not effective in adults using seasonal influenza strains, possibly due to pre-existing immunity to the prime, unmatched prime and boost antigens, or the lengthy 36 week boost interval. Careful optimization of the DNA prime-IIV3 boost regimen as related to antigen matching, interval between vaccinations, and pre-existing immune responses to influenza is likely to be needed in further evaluations of this vaccine strategy. In particular, testing this concept in younger age groups with less prior exposure to seasonal influenza strains may be informative. Trial Registration ClinicalTrials.gov NCT01498718

Published
2015

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