National Institute of Allergy and Infectious Diseases (NIAID)
Phase 1
2009-01-01
The purpose of this study is to look at the safety and immunogenicity of a combination
vaccine that includes tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis
(Tdap). The study will be conducted in 48 pregnant women and 32 non-pregnant women. Safety of
the newborn infant and the effect of the mother's vaccination on the infants' immune
responses prior to vaccinating infants with another combination vaccine to protect against
diphtheria, tetanus, and pertussis will be evaluated. Participants will be 18-45 years old.
Pregnant volunteers will be 30-32 weeks pregnant and at a low risk for pregnancy
complications. Pregnant volunteers will receive 2 injections (1 vaccine and 1 placebo,
inactive substance); non-pregnant volunteers will receive 1 injection of vaccine. Blood
samples will be collected from the mother and infant, along with the baby's growth
measurements. Participation for mother infant pairs is about 15 months and about 7 months for
non-pregnant women.
IDH1 Peptide Vaccine for Recurrent Grade II Glioma
Active, not recruiting
Gary Archer Ph.D.
Phase 1
2016-01-28
Potential subjects with progressive Grade II primary brain tumor that have IDH1 positive
testing from the primary tumor (initial diagnosis) will be offered this treatment study in
order to test the safety of the PEPIDH1M vaccine in combination with standard chemotherapy
(temozolomide).
Nivolumab With DC Vaccines for Recurrent Brain Tumors
Completed
Bristol-Myers Squibb
Phase 1
2016-01-01
Patients will be randomized to one of two treatment arms - Group I and Group II. Group I will
receive nivolumab monotherapy until surgical resection, and Group II will receive nivolumab
alone and with DC vaccine therapy until surgical resection. During surgical resection blood
and tumor samples will be assessed and compared. Following surgery, both groups will continue
to receive DC vaccines (total of 8) and nivolumab therapy until confirmed progression.
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