A Study to Evaluate Vaxart's Oral Bivalent GI.1/GII.4 Norovirus Vaccine in Healthy Lactating Fema… (NCT07254728) | Clinical Trial Compass
CompletedPhase 1
A Study to Evaluate Vaxart's Oral Bivalent GI.1/GII.4 Norovirus Vaccine in Healthy Lactating Females and Their Nursing Infants
South Africa76 participantsStarted 2023-10-27
Plain-language summary
The primary objective of this study is to evaluate the safety and tolerability of an oral bivalent GI.1/GII.4 norovirus vaccine administration in healthy lactating female participants and to assess the short-term immunogenicity of oral bivalent GI.1/GII.4 norovirus vaccine administration in healthy lactating female participants and its association with the immunogenicity response in breastmilk.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Lactating females aged ≥ 18 years at the time of enrolment and their breastfed infants aged \>30 days to 11 months of age at the time of the participants' study drug administration.
✓. In stable and good general health, without significant medical illness, based on medical history, physical examination (including vital signs), and clinical judgment of the investigator.
✓. Lactating females willing and able to provide informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
✓. Lactating females who are willing to provide consent for their breastfed infant.
✓. Negative pregnancy tests at screening and prior to dose on Day 1.
✓. Available for all planned visits and tele-health appointments, and ability to comply with all study-related evaluations (including but not limited to having the ability and willingness to swallow multiple small enteric-coated tablets per study dose, express/pump breastmilk, and collect infant stool samples).
✓. Plan to continue breastfeeding as the main source of the infant's nutrition for at least 1 month (longer is preferred with goal of 6 months post dose if possible) from the time of study drug administration. Exclusive breastfeeding is acceptable but not necessary.
✓. The nursing infant is the product of a singleton pregnancy AND does not have any of the following:
Exclusion criteria
✕. Presence of a fever ≥ 38.0°C measured orally at baseline, on Day 1 prior to vaccination. (Assessment may be repeated once during screening period).
What they're measuring
1
Number of Participants (Mothers) With Any Solicited Symptoms of Reactogenicity for 1 Week Following Trial Dose
Timeframe: 1 week post study dose (8 days)
2
Number of Participants (Mothers) With Unsolicited Treatment-emergent Adverse Events (TEAEs)
Timeframe: 4 weeks post dose (29 days)
3
Geometric Mean Concentration (GMC) of Serum Viral Protein 1 (VP1) Specific (G1.1) Immunoglobulin A (IgA) on Days 1, 8 and 29
Timeframe: Days 1, 8 and 29
4
GMC of Serum VP1 Specific (G2.4) IgA on Days 1, 8 and 29
Timeframe: Days 1, 8 and 29
5
Geometric Mean Fold Rise (GMFR) From Day 1 to Day 8 of Serum VP1 Specific (G1.1) IgA From Day 1 to Day 8
Timeframe: Day 1 to Day 8
6
GMFR of Serum VP1 Specific (G1.1) IgA From Day 1 to Day 29
Timeframe: Day 1 to Day 29
7
GMFR of Serum VP1 Specific (G2.4) IgA From Day 1 to Day 8
✕. Acute disease within 72 hours prior to vaccination, defined as the presence of a moderate or severe illness (as determined by the Investigator through medical history and physical exam). (Assessment may be repeated once during screening period).
✕. Participants who have received antipyretic/analgesic medications within 24 hours prior to the intended vaccine administration.
✕. Positive human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) tests at the screening visit.
✕. History of hypersensitivity or allergic reaction to any component of the investigational vaccine, including but not limited to fish gelatin.
✕. History of serious reactions to vaccination such as anaphylaxis, respiratory problems, hives, or abdominal pain.
✕. Presence of significant uncontrolled medical or psychiatric illness (acute or chronic) including the institution of new medical/surgical treatment or significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months of screening and reconfirmed at baseline.
✕. History of significant pregnancy-related complications during this pregnancy, including but not limited to pre-eclampsia, eclampsia, or gestational diabetes unless a full resolution is documented.
GMFR of Serum VP1 Specific (G2.4) IgA From Day 1 to Day 29
Timeframe: Day 1 to Day 29
9
Number of Participants Who Achieved a 2-fold, 3-fold and 4-fold GMC Rise in Serum VP1 Specific (G1.1) IgA
Timeframe: Days 1, 8, 29 and 180
10
Number of Participants Who Achieve a 2-fold, 3-fold and 4-fold GMC Rise in Serum VP1 Specific (G2.4) IgA
Timeframe: Days 1, 8, 29 and 180
11
GMC of Breastmilk VP1 Specific (G1.1) IgA on Days 1, 8 and 29
Timeframe: Days 1, 8, and 29
12
GMC of Breastmilk VP1 Specific (G2.4) IgA on Days 1, 8 and 29
Timeframe: Days 1, 8 and 29
13
GMFR of Breastmilk VP1 Specific (G1.1) IgA From Day 1 to Day 8
Timeframe: Day 1 to Day 8
14
GMFR of Breastmilk VP1 Specific (G2.4) IgA From Day 1 to Day 8
Timeframe: Day 1 to Day 8
15
GMFR of Breastmilk VP1 Specific (G1.1) IgA From Day 1 to Day 29
Timeframe: Day 1 to Day 29
16
GMFR of Breastmilk VP1 Specific (G2.4) IgA From Day 1 to Day 29
Timeframe: Day 1 to Day 29
17
Number of Participants Who Achieve a 2-fold, 3-fold and 4-fold GMC Rise in Breastmilk VP1 Specific (G1.1) IgA
Timeframe: Days 1, 8, 29, 60 and 180
18
Number of Participants Who Achieve a 2-fold, 3-fold and 4-fold GMC Rise in Breastmilk VP1 Specific (G2.4) IgA