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P1096 / Phase 1 Study of Live Attenuated Recombinant (cp) 45 Human Parainfluenza Type 3 Vaccine

Phase 1 Study to Determine the Safety, Infectivity, and Tolerability of 2 Doses of Live Attenuated Recombinant Cold-passaged (cp) 45 Human Parainfluenza Type 3 Virus Vaccine, rHPIV3cp45, Lot PIV3#102A, Delivered as Nose Drops to HPIV3-Seronegative Infants and Children 6 to 36 Months of Age, at a 6 Month Interval

Study Status


DAIDS Number


IND Number

BB 12592

Clinical Trials Link


P1096 was a phase 1 randomized, double-blind, placebo-controlled, outpatient trial evaluating the safety, infectivity, tolerability, and immunogenicity of rHPIV3cp45, Lot PIV3#102A human parainfluenza virus type 3 (HPIV3) vaccine, delivered as nose drops. HPIV3-seronegative infants received 2 doses of vaccine or placebo, delivered approximately 6 months apart. This protocol was a companion protocol to CIR 255, a study being conducted by the Center for Immunization Research (Johns Hopkins, Baltimore) and the Laboratory of Infectious Diseases (NIAID, Bethesda). The primary objectives of the study were to determine the safety and immunogenicity of 2 doses of rHPIV3cp45, Lot PIV3#102A in 6 to 36-month-old HPIV3-seronegative infants.

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