Safety Evaluation of PfSPZ Vaccine in Pregnant Women in Mali (MalVIP1)

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Dec 14, 2022

Keywords

ClinConnect Summary

Study Description:

A randomized double blind, placebo-controlled study to assess the safety, tolerability, immunogenicity and protective efficacy of a 1, 8, 29-day regimen of 9x105 PfSPZ of PfSPZ Vaccine or placebo (normal saline) in healthy pregnant women and their fetus/newborn. The first immunization is to be administered at 16 0/7 to 32 6/7 weeks of gestation and targeted to be completed prior to delivery. Offspring and post-partum women will be followed for 12 months post-delivery.

The study is composed of two cohorts (3rd trimester: Arms 1A, 2A, 2nd trimester: Arms 1B, 2B) with two ...

Gender

ALL

Eligibility criteria

• * INCLUSION CRITERIA:
• • In order to be eligible to participate in this study, an individual must meet all of the following
• criteria:
• • Willing and able to provide consent for study participation for herself and for her infant prior to initiation of any study procedures
• • Stated willingness to comply with all study procedures and availability of both mother and offspring for the duration of the study
• • Healthy, pregnant women 18-34 years of age (inclusive)
• • Singleton pregnancy (confirmed by ultrasound)
• • Gestational weeks of pregnancy, confirmed by best obstetrical estimate, at minimum of 16 weeks 0 days and a maximum of 32 weeks 6 days of gestation at the time of the first dose of PfSPZ Vaccine and minimum 14 weeks 0 days and maximum of 32 week 0 days of gestation at the time of the first dose of IPTp
• • --Note: women may be screened prior to 16 0/7 weeks gestation for dating of pregnancy
• • Documented first, second, or third trimester ultrasound with singleton gestation and no significant fetal anomalies or other abnormalities
• • Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
• • Identified antenatal care provider outside of the study team
• • In good general health as evidenced by medical history
• • Willing to have blood samples stored for future research
• EXCLUSION CRITERIA:
• • An individual who meets any of the following criteria will be excluded from participation in this
• study:
• • Medical, behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and comply with the study protocol
• • Hemoglobin (Hgb), WBC, absolute neutrophils, and platelets outside the local laboratory defined limits of normal per trimester and \>= Grade 2 (participants may be included at the investigator s discretion for not clinically significant abnormal values)
• • Alanine transaminase (ALT) or creatinine (Cr) level above the local laboratory-defined (per trimester) upper limit of normal and \>= Grade 2 (participants may be included at the investigator s discretion for not clinically significant abnormal values)
• • Infected with HIV, hepatitis B, hepatitis C, syphilis, toxoplasmosis, rubella as documented by testing at screening
• • Sickle cell disease (HbSS or HbSC) or sickle trait (HbAS) by testing at screening
• • Clinically significant abnormal ECG such as abnormal QTc
• * History of receipt of the following:
• • Investigational malaria vaccine in the last 5 years
• • Immunoglobulins and/or blood products within 6 months of enrollment
• • Investigational product within 3 months of enrollment
• • Chronic (\>=14 days) oral or IV corticosteroids (excluding topical or nasal) at immunosuppressive doses (i.e., prednisone \>=20 mg/day or equivalent) or immunosuppressive drugs within 30 days of enrollment
• • Live vaccine within 30 days of enrollment
• • Non-live vaccine within 14 days of enrollment or planned receipt of a killed vaccine within 14 days of scheduled vaccination
• * Known medical problems:
• • Pre-existing autoimmune or antibody-mediated diseases (e.g. systemic lupus erythematosus,
• • rheumatoid arthritis, multiple sclerosis, Sj(SqrRoot)(Delta)gren s syndrome, or autoimmune thrombocytopenia)
• • Severe asthma (defined as asthma that is unstable or required emergent care, urgent care, hospitalization, or intubation during the past two years, or that has required the use of oral or parenteral corticosteroids at any time during the past two years)
• • Immunodeficiency disorder
• • Asplenia or functional asplenia
• • Diabetes (inclusive of Type 1, 2, or gestational)
• • Deep venous thrombosis or thromboembolic event (current or prior history)
• • Seizures (exception is simple febrile seizures during childhood)
• • History of prior uterine surgery
• • Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, hematological, oncologic, or renal disease by history, physical examination, and/or laboratory studies
• • Medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months
• • History of a severe allergic reaction or anaphylaxis following previous vaccinations or medications
• • Known allergies or other contraindications against: PfSPZ Vaccine, human serum albumin
• • Positive screening testing or diagnostics for entities (pathogens, diseases) deleterious to pregnancy
• • Nullipara (P\<1) or grandimultipara (P\>=5)
• • Body mass index (BMI) at enrollment \>=30
• * Prior or current pregnancy history of:
• • 2 or more spontaneous miscarriages
• • Any unexplained stillbirths
• • Any unexplained neonatal deaths
• • Infant with major congenital anomalies
• • Infant with known genetic disorder
• • Preterm deliveries (\< 37 0/7 WGA)
• • Severe pre-eclampsia and/or eclampsia
• • Gestational hypertension
• • Gestational diabetes
• • Red blood cell isoimmunization
• • Cervical insufficiency or incompetent cervix
• • Polyhydramnios or oligohydramnios
• • Premature contractions or preterm labor
• • Bleeding through gestation
• • Known intrauterine fetal growth restriction
• • Use of anti-coagulants during pregnancy
• • Receipt of progesterone during current pregnancy
• • Prior Cesarean section
• • Documentation that current pregnancy results from rape or incest
• • Other condition(s) that, in the opinion of the investigator, would jeopardize the safety or rights of a participant participating in the trial, interfere with the evaluation of the study objectives, or would render the participant unable to comply with the protocol

Trial Officials