People's stomachs: a new generation rotavirus vaccine for children has been tested at the Gamaleya center

The specialists of the N.F. Gamalei National Research Center have completed clinical trials of a new vaccine against rotavirus infection in children aged nine months to six years. The developers have confirmed the safety and effectiveness of the drug. Now they have started research involving children aged eight to 32 weeks, the main target group for vaccination. The creators expect that after the completion of this stage in September and the registration procedure, the vaccine will enter circulation in 2026. The drug is specially designed to protect against those genotypes of the virus that are characteristic of our country. According to doctors, a new third-generation vaccine has long been needed to protect children and adults.

New Russian rotavirus vaccine

The specialists of the N.F. Gamaleya National Research Center have successfully completed clinical trials of a new rotavirus vaccine in children aged nine months to six years. Experiments have confirmed the safety and immunogenicity of the drug. The scientists plan to submit an application for registration of the development for use in this age group in June. They are now moving on to the next stage of trials in patients aged eight to 32 weeks. This is the main target group for medical professionals. According to the law, in order to test a drug on children in the first months of life, you first need to test the effect of the vaccine on adults and older children. This part of the work was completed at the Gamaleya Center. The research on babies should be completed by the end of the summer.

— For older children, we will apply for registration in June. And with the end of the clinical trial in the target group, we will apply in September. We hope that we will receive registration for children of all ages. But when this happens does not depend solely on us. The Center of Expertise will review the application. I hope the vaccine will be introduced into civil circulation in 2026," Tatyana Grebennikova, head of the Laboratory of Molecular Diagnostics at the N.F. Gamaleya Federal Medical Research Center, told Izvestia.

The new rotavirus drug is a hexavalent vaccine that includes six genotypes of the pathogen. The patient develops antibodies against them after the injection. They also protect against two more genotypes through cross-immunity. Thus, the development is particularly effective against all eight genotypes of rotavirus infection, which are most typical for Russia. The vaccine created at the scientific center belongs to the third generation, that is, it combines high immunogenicity and safety. Scientists have managed to achieve such properties through the use of virus—like particles, virions, which are very similar to rotaviruses, but do not contain their DNA.

— We synthesized protein virions in insect cells. They are similar to rotavirus in everything, but they do not contain any genetic material. After the injection, the body is deceived in the good sense of the word, thinks that the virus has arrived, and produces antibodies. After that, the protein particles simply break down with monthly kinetics and are excreted by the body. That is why the platform of virus-like particles is considered very promising. This is a third-generation vaccine. This is when we make them safe, but their effectiveness is comparable to live vaccines," said Tatiana Grebennikova.

A drug based on virus-like particles

The vaccine protects against infection with the virus. Scientists have proven that immunity persists for at least a year. It is possible that the effect of the vaccine lasts longer, however, longer observations are needed to find out. Three injections are needed to vaccinate the youngest children. For revaccination of older patients, a single injection of the drug may be sufficient. No serious side effects of the drug have been identified.

Currently, a pentavalent vaccine containing fragments of live viruses is used in the Russian Federation to protect children from rotavirus. According to experts, the drug is not safe enough for use in the youngest age group.

— All the vaccines that are available are based on a live virus. This, of course, is not as safe as using protein particles. That's why we're promoting this platform. In the existing pentavalent vaccine, live viruses are resortants, in my opinion, they are bovine and human. And they use rotavirus genotypes without taking into account Russian strains. In general, for young children, injecting five live viruses is probably not so safe after all," said Tatiana Grebennikova.

According to the expert, vaccination with the new drug for children aged eight to 32 weeks is likely to be included in the vaccination calendar. At the same time, it can also be used to protect older patients, as it is known that rotavirus infection is difficult for children under five years of age. There will probably also be a special version for adults.

What is the danger of rotavirus?

The lack of a modern Russian rotavirus vaccine was a serious technological gap that needs to be filled, said Mikhail Bolkov, a researcher at the Institute for the Study of Aging at the Russian State Scientific and Clinical Center of the Pirogov Russian National Research Medical University of the Russian Ministry of Health. Virus-like particles can enter a cell, but they cannot do anything wrong with it, so they are well suited for a vaccine.

— Rotavirus is called the summer intestinal flu. It causes viral diarrhea and mainly affects children. It is especially dangerous for up to two years, as it leads to severe dehydration and intoxication. And up to six months is an even more vulnerable group. In the worst case, there may be a fatal outcome, so vaccination is necessary. In any case, it's better than getting sick, both for children and adults. It's good that the vaccine protects against eight variants of the virus at once, as the pathogen will spread less in the population," the expert said.

According to Andrey Prodeus, chief pediatric allergist and immunologist at the Ministry of Health of the Moscow Region, doctors need a modern and safe rotavirus vaccine.

— This is one of the most unpleasant intestinal infections in young children. It is very important to be able to protect a child from it, especially from diarrhea and dehydration, which it causes. It is also important to have a drug that is based on our Russian infection strains," he said.

Now, to get the desired effect, existing vaccines need to be administered to a child between 2.5–3 and 6-8 months of age. The new drug will have a larger range, which is also very important, the doctor stressed.