Vaccine for Zika

Not currently recruiting at 3 trial locations

Overseen By Chief Medical Officer

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Valneva Austria GmbH

Must not be taking: Immunosuppressants, Cytotoxic drugs

Disqualifiers: Flavivirus history, HIV, Hepatitis, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 399

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vaccine, VLA1601, to evaluate its safety and effects on the body's immune response to the Zika virus. Researchers are experimenting with different doses to determine the optimal one. Participants will receive two vaccine shots and undergo monitoring for any reactions and changes in immunity. This trial may suit generally healthy adults who have never been exposed to Zika or similar viruses and have not recently traveled to areas with active Zika transmission. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new vaccine.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on immuno-suppressive therapy, you must have stopped it at least 4 weeks before the first vaccination.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on immuno-suppressive therapy, you must have stopped it at least 4 weeks before the first vaccination. It's best to discuss your specific medications with the trial investigator.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found Valneva's Zika vaccine candidate, VLA1601, to be safe. Participants generally tolerated the vaccine well, experiencing no serious side effects. Common side effects included mild fever, muscle aches, nausea, and tiredness, which are typical and not severe. Data up to 57 days after the second dose confirmed the vaccine's safety across different groups. These results suggest that VLA1601 is safe for human use. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about VLA1601 because it represents a novel approach to preventing Zika virus infection. Unlike traditional vaccines, VLA1601 is formulated with varying doses and includes innovative adjuvants like CpG 1018® and 3M-052-AF, which are designed to enhance the body's immune response. This could potentially offer more robust and longer-lasting protection against the Zika virus. Additionally, the use of different dosing strategies, such as low, medium, and high doses, allows for optimization of the vaccine's effectiveness and safety profile. These features make VLA1601 a promising candidate in the fight against Zika, setting it apart from existing treatments.

What evidence suggests that this trial's treatments could be effective for Zika?

Research has shown that the VLA1601 vaccine produced promising results in earlier studies. It was generally safe for participants at different dose levels. In this trial, participants will receive varying doses of VLA1601, with some groups receiving the vaccine with adjuvants like CpG 1018® or 3M-052-AF. The vaccine helped the body recognize and fight the Zika virus effectively. This immune response improved when certain substances, called adjuvants, were added to the vaccine. These findings suggest that VLA1601 could effectively protect against the Zika virus. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for healthy adults who can participate in a study testing a new Zika virus vaccine. Participants will receive two doses of the vaccine, with some getting additional ingredients to boost their immune response.

Inclusion Criteria

I agree to use birth control for 3 months after my last vaccine dose.

BMI of ≥18.5 and <30 kg/m2

Generally healthy as determined by the investigator's clinical judgement based on medical history, physical examination, and screening laboratory tests

Exclusion Criteria

Tests positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)

With a history of severe hypersensitivity reactions or anaphylaxis

With a history of any vaccine related contraindicating event

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

3 weeks

Open-label Run-in

Initial open-label sentinel run-in phase with staggered dose-escalation for 25 participants

4 weeks

2 visits (in-person)

Randomized Treatment

Randomized, double-blind, dose-finding phase with two vaccinations on Day 1 and Day 29

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and immune response up to 6 months after the second vaccination

6 months

Phone calls and on-site visit at Day 395 for selected participants

What Are the Treatments Tested in This Trial?

Interventions

• VLA1601

Trial Overview The trial is examining three different dose levels of VLA1601, a Zika virus vaccine candidate, mixed with adjuvants CpG1018® or 3M-052-AF/AP 60-702. The goal is to find the safest and most effective dose for inducing an immune response.

How Is the Trial Designed?

Group I: VLA1601 Medium dose Experimental Treatment 1 Intervention

Group II: VLA1601 Low dose + CpG 1018® Experimental Treatment 2 Interventions

Group III: VLA1601 Low dose + 3M-052-AF Experimental Treatment 2 Interventions

Group IV: VLA1601 Low dose Experimental Treatment 1 Intervention

Group V: VLA1601 High dose Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Valneva Austria GmbH

Lead Sponsor

Trials

46

Recruited

59,100+

Published Research Related to This Trial

Zika virus, which caused a public health emergency due to its association with microcephaly in newborns, has prompted urgent efforts to develop vaccines, with various strategies being explored including live attenuated, inactivated, DNA, and viral vectored vaccines.

The first clinical trials for Zika virus vaccine candidates were set to begin in late 2016, but the process for getting a vaccine approved is expected to take several years, highlighting the need for accelerated development to ensure timely availability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaccine Development for Zika Virus-Timelines and Strategies. Durbin, AP.[2018]

A total of 63 potential T cell epitopes were identified from the Zika virus, with nine promising candidates showing strong binding affinity to various human leukocyte antigen class I supertypes, indicating their potential for generating effective immune responses.

These selected epitopes demonstrated high conservancy across Zika virus strains and minimal similarity to human proteins, suggesting a low risk of autoimmunity, and they could provide over 99% population coverage globally, making them strong candidates for a future Zika vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computational prediction and analysis of potential antigenic CTL epitopes in Zika virus: A first step towards vaccine development. Dikhit, MR., Ansari, MY., Vijaymahantesh, ., et al.[2017]

Multiple Zika vaccine platforms, including inactivated virus and nucleic acid vaccines, are currently in human clinical trials, showing promising results from recent phase I trials.

Despite a decrease in transmission rates, Zika virus remains endemic in the Americas, highlighting the urgent need for continued vaccine development to prepare for potential future outbreaks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Glimmer of Hope: Recent Updates and Future Challenges in Zika Vaccine Development. Castanha, PMS., Marques, ETA.[2021]

Zika virus infection can lead to serious health issues, including Congenital Zika Syndrome, which has prompted urgent efforts to develop vaccines and treatments, especially following the 2015 epidemic.

Research has shown that various vaccine candidates are safe and can generate immune responses in early human trials, but the decline in Zika transmission has hindered the ability to conduct trials that measure their effectiveness in preventing the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zika vaccine pre-clinical and clinical data review with perspectives on the future development. Thomas, SJ., Barrett, A.[2023]

The engineered NILV-based Zika vaccine demonstrated strong immunogenicity, producing robust neutralizing antibodies and providing full protection against Zika virus in mouse models just 7 days after a single dose.

This vaccine also conferred long-lasting immunity, remaining effective even 6 months post-immunization, highlighting its potential as a rapid and durable solution for Zika virus outbreaks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Single Dose of NILV-Based Vaccine Provides Rapid and Durable Protection against Zika Virus. Ku, MW., Anna, F., Souque, P., et al.[2021]

The Zika purified inactivated virus (ZPIV) vaccine was found to be safe and well tolerated in healthy adults, with no serious treatment-related adverse events reported during a 52-week follow-up period.

Immunogenicity of ZPIV required two doses for effective antibody response, with the standard regimen showing the highest peak neutralizing antibody levels, but antibody levels declined significantly after 16 weeks, indicating the need for further studies to optimize dosing schedules.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of a Zika purified inactivated virus vaccine given via standard, accelerated, or shortened schedules: a single-centre, double-blind, sequential-group, randomised, placebo-controlled, phase 1 trial. Stephenson, KE., Tan, CS., Walsh, SR., et al.[2023]

Researchers have made significant progress in developing various Zika virus vaccine candidates, including inactivated virus, live attenuated virus, and viral vector vaccines, with many advancing to clinical trials.

The primary goal of Zika vaccination is to prevent the transmission of the virus from pregnant women to their unborn babies, necessitating unique safety and efficacy standards for these vaccines compared to those for other diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent Advances in Zika Virus Vaccines. Garg, H., Mehmetoglu-Gurbuz, T., Joshi, A.[2023]

The novel Zika virus vaccine, MVA-ZIKV, developed using a modified vaccinia virus, effectively produced neutralizing antibodies and strong CD8+ T cell responses in mice, indicating its potential for robust immune protection.

A single dose of MVA-ZIKV significantly reduced viral levels in immunocompromised mice infected with live Zika virus, demonstrating its efficacy in preventing Zika virus infection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Vaccine Based on a Modified Vaccinia Virus Ankara Vector Expressing Zika Virus Structural Proteins Controls Zika Virus Replication in Mice. Pérez, P., Q Marín, M., Lázaro-Frías, A., et al.[2019]

In a systematic review of five phase-1 clinical trials involving candidate anti-Zika vaccines, all vaccines demonstrated high immunogenicity, with seroconversion rates ranging from 10% to 100%, particularly showing the highest rates for DNA vaccines after multiple doses.

The candidate vaccines were generally well-tolerated, with most adverse events being mild and localized, such as injection site pain, while systemic effects like fever and fatigue were also reported, indicating a favorable safety profile for further development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of Zika virus vaccine: A systematic review of clinical trials. Yeasmin, M., Molla, MMA., Masud, HMAA., et al.[2023]

Citations

1. valneva.com valneva.com/research-development/zika/

Zika - VLA1601 - Valneva Phase 1 results from Valneva's first-generation Zika vaccine candidate were reported in 2018 showing a favorable safety profile and immunogenicity in all tested ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06334393

Study Details | NCT06334393 | Phase 1 Trial to Assess the ... Phase 1 Trial to Assess the Safety and Immunogenicity of an Inactivated, Adjuvanted Whole Zika Virus Vaccine Candidate (VLA1601) in Healthy Adults.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36377643/

A randomized, placebo-controlled, blinded phase 1 study ... Results: Our vaccine candidate showed an excellent safety profile independent of dose and vaccination regimen with predominantly mild adverse ...

4. yahoo.com yahoo.com/news/articles/valneva-announces-positive-data-vla1601-094817986.html

Valneva announces positive data for VLA1601 in Phase I trial Data gathered up to day 57 after the second dose indicated that VLA1601 was generally well tolerated and safe across all five treatment groups.

5. vax-before-travel.com vax-before-travel.com/vaccines/zika-vaccine-vla1601

Zika Vaccine VLA1601 The immune response induced by the double-adjuvanted VLA1601 vaccine candidate was successfully improved compared to the first-generation vaccine candidate, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10077998/

Safety and immunogenicity of Zika virus vaccine The most common systemic AEs included fever, myalgia, nausea, and fatigue. In phase‐1 clinical trials, all candidate vaccines were found to be highly ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2590136225001007

Safety and immunogenicity of inactivated Zika virus ... Importantly, the gamma-irradiated ZIKV was well tolerated, with no signs of adverse effects, supporting its safety in a preclinical setting. These results ...

8. clinicaltrialsarena.com clinicaltrialsarena.com/news/valneva-positive-data-vla1601-trial/

Valneva announces positive data for VLA1601 in Phase I trial Data gathered up to day 57 after the second dose indicated that VLA1601 was generally well tolerated and safe across all groups. November 5, ...