A Zika virus vaccine clinical trial

Trial ID: NCT04917861

A clinical trial conducted by Moderna is evaluating an investigational vaccine that may protect people from Zika virus. Zika virus can cause fever, rash, joint pain, headache, neurological complications, and even pregnancy complications. It is primarily transmitted to people by mosquito bite. It can also be sexually transmitted from an infected person to a partner or transmitted from a pregnant individual to their baby during pregnancy or birth. Currently, there is no approved treatment for this condition.

Trial Details

The mRNA-1893-P201 Trial is evaluating the safety of and immune response to an investigational vaccine, called mRNA-1893, to see if it is safe for broad vaccination use and if it may provide protection against Zika virus. Participation in the mRNA-1893-P201 trial lasts about seven months with the option to enter an extension period, which would extend the total length of participation to about two years. Those who are eligible to participate and decide to enroll will receive two injections - an initial injection and then a second injection approximately 28 days later - in the upper arm.

Estimated Enrollment

800 Participants

Phase

2

Eligibility Criteria

Participants must:

Be between 18 and 65 years old
Be in generally good health, or with clinically stable chronic medical

Participants must not:

Have received any vaccines, including a COVID-19 vaccine, within 28 days of the first injection in this trial
- Participants may still receive flu vaccinations during the trial as long as those vaccines are administered 14 days before or after a trial injection
Have received any prior Zika or dengue vaccines
Be pregnant or planning to become pregnant at any time while enrolled in the trial

What to Expect

You will need to travel to one of the study clinics taking part in this clinical trial. Sites are located in:

Actively Recruiting

San Juan, Puerto Rico, United States
Lenexa, Kansas, United States
Guayama, Puerto Rico, United States
Ponce, Puerto Rico, United States

Not yet Recruiting

(Awaiting confirmation) San Juan, Puerto Rico, United States
(Awaiting confirmation) Fort Worth , Texas, United States
(Awaiting confirmation) Sioux City, Iowa, United States

Participation in the mRNA-1873-P201 trial lasts about seven months and includes phone calls and up to eight visits to the trial site. Participants will have the option to enter an extension period, which would extend the length of participation to about two years with 11 total visits to the trial site.

Participants will be given two injections in the upper arm. The second injection will be approximately 28 days after the initial injection. Participants have a chance of receiving either the mRNA-1893 investigational vaccine or a placebo. By using a placebo, medical researchers are able to compare the side effects of mRNA-1893 vaccine with a saline placebo and to understand if the investigational vaccine might be effective in protecting against zika virus.
Participants will be asked to return to the study site for follow up visits and will also have phone calls with the study site to monitor for any symptoms. During these phone calls, the doctor and medical staff will check how you are feeling and ask for updates on your health.
Paricipants will be asked to complete an eDiary every day for the first seven days after their investigational vaccine injections to report any symptoms they might experience after each injection.
Participants will be closely monitored by the clinical research team if any symptoms are reported at any time throughout participation.

Insurance is not needed to join this clinical trial, and compensation for participants’ time will be offered.

Frequently Asked Questions (FAQs)

What is Zika Virus?

Zika virus is a mosquito-borne virus that can cause fever, rash, joint pain, headache, neurological complications, and even pregnancy complications. Currently there is no approved treatment for this condition, but right now, research is underway to evaluate an mRNA-based vaccine.

What is a clinical trial?

Clinical trials are carefully controlled scientific studies that evaluate how well investigational or modified medicines may treat or prevent diseases in people. Clinical trials are conducted to answer questions such as:

Is the investigational treatment or vaccine safe enough to outweigh the risks?
What is the best dose needed for the investigational treatment or vaccine to work?
How often should the investigational treatment or vaccine be given?
How effective is the investigational treatment or vaccine at treating or preventing symptoms or the condition?

A clinical trial follows a protocol that has been approved by the FDA and other regulatory agencies in order to ensure the safety of trial volunteers. The protocol outlines the types of trial participants to include, the schedule of visits and procedures, safety precautions, and what and how data will be analyzed.

What are the phases of clinical research?

All new treatments and vaccines must go through several stages of research (also called “phases”) in order to determine if the new treatment or vaccine is safe and effective in people. Clinical trials are usually conducted in four phases that build on one another, with each phase designed to answer certain questions.

Preclinical Research:__ Before testing in people, investigational treatments undergo laboratory and animal testing to answer basic questions about safety.
Phase 1: A trial of a small number of participants to evaluate the safety and dosage of an investigational treatment or vaccine and gather information on how it interacts with the body.
Phase 2: A trial of a slightly larger group of participants to further evaluate how an investigational treatment or vaccine affects the body, gather additional safety data, and monitor side effects.
Phase 3: A trial with the largest number of participants to determine efficacy of an investigational treatment or vaccine and compare it to existing treatments, vaccines, or placebo. A Phase 3 trial continues to monitor side effects and collect safety data. This is the final step before submitting an investigational product to a regulatory agency for market approval.
Regulatory Agency Review: Regulatory agencies, such as the FDA in the United States, review data from the clinical trial and determine if the investigational treatment or vaccine is effective and safe for use in people. To get approved, the new treatment or vaccine must be determined to provide benefits that outweigh its known and potential risks for the intended population.
Phase 4:__ After receiving approval, the treatment or vaccine is made available for use. Phase 4 trials are used for post-marketing observation. Sometimes, they may be used to study the medicine or vaccine in a different group of people or in another illness or disease than was previously studied. Not all medications and treatments will require a Phase 4 trial.

Reference: https://www.fda.gov/patients/learn-about-drug-and-device-approvals/drug-development-process

Why is diversity important in clinical trials?

Clinical trials and study volunteers are vital to developing a vaccine that will protect people of all ages and from all backgrounds.

Given that certain populations and ages can respond differently to medical therapies, it is extremely important that this clinical trial include people of all ages, genders, races and ethnicities to ensure the vaccine is safe and effective for everyone to use.

Will compensation for time be available as part of this clinical trial?

Yes, compensation for participants’ trial-related time spent will be offered. The clinical research staff will review these details with participants.

Does the mRNA-1893 investigational vaccine contain a live virus?

Often vaccines for viruses are made from a weakened or inactive (not live) virus, but the mRNA-1893 investigational vaccine is different. It is made from an instructional molecule called mRNA that tells your cells how to make protein. In this case, the protein is a small part of the virus that is thought to help the body’s immune system protect itself if you ever come in contact with the Zika Virus.

What is a comparator or placebo?

In order to better know if the investigational treatment or vaccine works, researchers may compare the investigational treatment or vaccine to an inactive drug called a placebo, which can be a sugar pill or saltwater solution. A placebo looks like the investigational treatment or vaccine being tested but does not contain an active ingredient.

All participants receive the same level of quality care regardless of whether they are assigned to the investigational treatment or vaccine, or the placebo.

How can I check to see if I am eligible for this trial?

You can check if you are potentially eligible for this trial by completing a set of screening questions. You can find these on this web page by clicking the ‘Get Started’ button.

Can participants quit the trial at any time?

Participation in any clinical trial is completely voluntary. Participants have the right to drop out of the trial at any time and for any reason (and they do not need to give a reason). The clinical trial doctor or clinical research sponsor also has the right to discontinue a participant at any time for the participant’s safety, if the participant no longer meets the clinical trial requirements or if the participant does not comply to the study procedures.

This trial is not actively recruiting.