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Table 3 Perinatal Adverse Events

From: A retrospective analysis of incident pregnancy in phase 1 and 2a HIV-1 vaccine study participants does not support concern for adverse pregnancy or birth outcomes

  Adverse Fetal Events Adverse Maternal Events
Severity Event Severity Event
Product recipients (n = 154 pregnancies) Severe Congenital anomaly in offspring Death Shock
Severe Congenital anomaly in offspring (Poland’s syndrome) Life Threatening HIV infected
Severe Hepatic Mesenchymal Hamartoma in Offspring Severe Pelvic Pain
   Severe Placenta previa
   Moderate Back Pain r/t herniated disk
   Moderate Gastritis
   Moderate Headache
   Moderate Infected wisdom teeth - upper left + lower left
   Moderate Insomnia
   Moderate Left chest pains
   Moderate Proteinuria
   Moderate Sinusitis
   Moderate Vaginal colonization with Group B strep
   Moderate Wisdom teeth impaction - upper left + lower left
Placebo recipients (n = 39 pregnancies)    Severe Incomplete abortion
   Severe Increase interval (432 ms) from baseline QTc interval
   Moderate Macro hematuria post therapeutic abortion
   Moderate Pre-eclampsia
   Moderate Retained placenta (with postpartum pyrexia)