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A Study to Evaluate Vaxart's Oral Bivalent GI.1/GII.4 Norovirus Vaccine in Healthy Lactating Females and Their Nursing Infants | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study to Evaluate Vaxart's Oral Bivalent GI.1/GII.4 Norovirus Vaccine in Healthy Lactating Females and Their Nursing Infants

A Phase I, Multicenter, Randomized, Double-blind, Placebo-controlled Single Dose, Dose-ranging Study to Evaluate the Safety, Tolerability, and Immunogenicity of Orally Administered Bivalent GI.1/GII.4 Norovirus Vaccine in Healthy Lactating Females ≥ 18 Years Old and Their Breast-feeding Infants

NCT07254728•Vaxart

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•1. 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.
•2. 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.
•3. 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.
•4. Lactating females who are willing to provide consent for their breastfed infant.
•5. Negative pregnancy tests at screening and prior to dose on Day 1.
•6. 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).
•7. 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.
•8. The nursing infant is the product of a singleton pregnancy AND does not have any of the following:
•1. Any abnormality that may interfere with breastfeeding or milk absorption
•2. Active infection (may be included if the infection resolves and the participant is re-assessed during the screening period)
+8 more criteria

Exclusion Criteria

•1. 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).
•2. 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).
•3. Participants who have received antipyretic/analgesic medications within 24 hours prior to the intended vaccine administration.
•4. Positive human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) tests at the screening visit.
•5. History of hypersensitivity or allergic reaction to any component of the investigational vaccine, including but not limited to fish gelatin.
•6. History of serious reactions to vaccination such as anaphylaxis, respiratory problems, hives, or abdominal pain.
•7. 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.
•8. 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.
•9. Cancer, or treatment for cancer, within the past 3 years (excluding fully treated and resolved basal cell carcinoma or squamous cell carcinoma).
•10. Presence of immunosuppression or medical condition possibly associated with impaired immune responsiveness, including diabetes mellitus type 1 or 2.
+40 more criteria

Locations (5)

WITS RHI Research Centre

Hillbrow, South Africa

Progress Clinical Research Unit

Honeydew, South Africa

Newtown Clinical Research Centre

Johannesburg, South Africa

Trident Clinical

Kimberley, South Africa

FCRN Clinical Trials Centre (Pty) Ltd

Vereeniging, South Africa

Key Dates

Start Date

October 27, 2023

Primary Completion Date

December 13, 2024

Completion Date

December 13, 2024

Last Updated

November 28, 2025

Enrollment

ACTUAL participants

Conditions

Norovirus Infections

Interventions

VXA-G1.1-NN

BIOLOGICAL

VXA-G2.4-NS

BIOLOGICAL

Placebo Tablets

BIOLOGICAL

A Trial of a Norovirus G1.1 and G2.4 Vaccine Administered Orally to Healthy Participants Aged ≥ 18 Years and ≤ 80 Years Old

NCT06944717

Norovirus Infections

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COMPLETEDPHASE1/PHASE2

Immunogenicity & Safety Study of Adenovirus Type 5 (AD5) Based Oral Norovirus Vaccines

NCT04875676

Norovirus Infections

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COMPLETED

Admission Pattern Among Children With Gastro-intestinal Infections Before and During the Covid-19 Pandemic

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate Vaxart's Oral Bivalent GI.1/GII.4 Norovirus Vaccine in Healthy Lactating Females and Their Nursing Infants

Inclusion Criteria

Exclusion Criteria

A Trial of a Norovirus G1.1 and G2.4 Vaccine Administered Orally to Healthy Participants Aged ≥ 18 Years and ≤ 80 Years Old

Immunogenicity & Safety Study of Adenovirus Type 5 (AD5) Based Oral Norovirus Vaccines

Admission Pattern Among Children With Gastro-intestinal Infections Before and During the Covid-19 Pandemic

Clinical Trial to Evaluate the Recombinant Norovirus Bivalent (GI. 1 / GII. 4) Vaccine (Hansenula Polymorpha)

A Clinical Trial to Evaluate the Safety and Immunogenicity of Norovirus Bivalent Vaccine