What side effects are associated with this type of intervention?

Common treatments for gastroenteritis include oral rehydration solutions (ORS), antiemetics, and occasionally antibiotics. ORS is generally well-tolerated but can sometimes cause mild nausea or vomiting. Antiemetics like ondansetron may cause side effects such as headache, dizziness, or constipation. Antibiotics, when used, can lead to side effects like diarrhea, allergic reactions, or antibiotic resistance. Vaccines for gastroenteritis, such as the rotavirus vaccine, are generally safe but can cause mild side effects like irritability, mild diarrhea, or fever.

What prior FDA approvals exist?

The FDA has approved several treatments for gastroenteritis, primarily focusing on rehydration solutions and vaccines. For instance, the rotavirus vaccines, such as RotaTeq and Rotarix, are approved to prevent rotavirus gastroenteritis in infants and young children. These vaccines work by enhancing the immune response to the rotavirus, thereby preventing severe gastroenteritis. While there are no direct FDA approvals for treatments exactly like HIL-214, which aims to enhance the immune response to pediatric vaccines, the concept of using vaccines to prevent gastroenteritis is well-established.

What other types of research exist?

Promising alternatives to HIL-214 for enhancing immune response to pediatric vaccines in gastroenteritis patients include the Shigella sonnei 1790GAHB vaccine, which has shown safety and immunogenicity in Phase 1 studies, and Shigella conjugate vaccines (Shigella sonnei-CRM9 and Shigella flexneri type 2a-rEPAsucc), which have demonstrated safety and immunogenicity in children. These vaccines target common gastrointestinal pathogens and could be effective in preventing gastroenteritis.

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HIL-214 with Pediatric Vaccines for Gastroenteritis

Phase 2 & 3

Waitlist Available

Research Sponsored by HilleVax

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Summary

This trial tests a new vaccine called HIL-214 in healthy infants to protect them from norovirus. The vaccine aims to teach their immune systems to fight off the virus. Infants are targeted because they are at high risk for severe illness from norovirus.

Who is the study for?

Healthy infants aged 2 months (+14 days) can join this trial. They must be in good health as confirmed by medical history and physical exams, with no growth abnormalities or serious chronic diseases. Infants with severe reactions to vaccines, certain infections, or a history of immune system issues are excluded.

What is being tested?

The trial is testing HIL-214's safety and its effect on the body's response to routine pediatric vaccines compared to a placebo. It's double-blind (neither doctors nor participants know who gets what), randomized (assigned by chance), and involves two doses of HIL-214.

What are the potential side effects?

While specific side effects aren't listed here, the study will monitor infants for any adverse reactions due to HIL-214 when given alongside their regular vaccinations.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Immunogenicity Response

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ExperimentalExperimental Treatment1 Intervention

HIL-214 (1 dose at 4 months of age and 1 dose at 6 months of age) and routine childhood vaccines according to schedule.

Group II: PlaceboPlacebo Group1 Intervention

Placebo (1 dose at 4 months of age and 1 dose at 6 months of age) and routine childhood vaccines according to schedule.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

HIL-214

2023

Completed Phase 3

~460

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for gastroenteritis include oral rehydration solutions (ORS), probiotics, and in some cases, vaccines. ORS works by replenishing lost fluids and electrolytes, which is crucial for preventing dehydration. Probiotics help restore the natural balance of gut bacteria, which can be disrupted during gastroenteritis. Vaccines, such as the rotavirus vaccine, stimulate the immune system to recognize and fight off the virus, preventing future infections. The HIL-214 trial focuses on enhancing the immune response to vaccines, which is particularly important for gastroenteritis patients as it can provide long-term protection and reduce the severity and frequency of infections.

Activation patterns of murine B cells after oral administration of an encapsulated soluble antigen.Attempts to induce tolerance to Trichostrongylus colubriformis infection in sheep.Inactivated rotavirus vaccine by parenteral administration induces mucosal immunity in mice.