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Fifty to 100 children will be selected to participate in a clinical trial at Rutgers University for a Lyme disease vaccine being developed by Pfizer and French vaccine manufacturer Valneva.

The trial will “evaluate the safety and efficacy of a vaccine for the prevention of Lyme disease in children over the age of 5.” It will take place at the Pediatric Clinical Research Center at Rutgers Robert Wood Johnson Medical School in New Brunswick, New Jersey.

The Rutgers trial site will serve as one of approximately 50 trial sites nationwide and will enroll 50 to 100 children between the ages of 5 and 17 who have not been diagnosed with Lyme disease in the past three months.

The study will run for two years and include a total of 3,000 children.

There are no vaccines approved for Lyme disease, which according to data from the Centers for Disease Control and Prevention, affects approximately 476,000 Americans and is more common in children and teenagers.

According to Rutgers, 3 of 4 trial participants will be given doses of the candidate vaccine, receiving three doses in the first six months and a booster dose one year later. The remaining participants will receive a placebo.

Participants will be required to have six follow-up visits for clinical evaluation, and two follow-up phone calls with the study team as part of their involvement in the trial.

Dr. Sunanda Gaur, director of Rutgers’ Pediatric Clinical Research Center, said in a statement:

“Developing a vaccine is important because currently the only prevention is protecting children from tick bites through clothing and insect repellant and then checking them for ticks after they play outside, especially if they are in the woods or in grassy areas …

“They are most at risk during the spring and summer when ticks are most active.”

FDA fast-tracked Lyme disease vaccine in 2017

According to Pfizer, VLA15, is the only Lyme disease vaccine candidate in clinical development. Valneva began development work for VLA15 in 2017 after the U.S. Food and Drug Administration (FDA) issued it a Fast Track designation.

VLA15 is a “multivalent protein subunit vaccine,” targeting “the outer surface protein A (OspA) of Borrelia,” the bacteria that causes Lyme disease, according to Pfizer.

Valneva and Pfizer entered into a collaboration agreement in April 2020, after Valneva sold the rights for VLA15 to Pfizer for $130 million.

The Phase 3 clinical trial of VLA15, operating under the name “Vaccine Against Lyme for Outdoor Recreationists” (VALOR), was announced Aug. 8, 2022, with trial sites in the U.S., Finland, Germany, the Netherlands, Poland and Sweden.

Phase 3 has been fraught with difficulties, however. On Feb. 17, Pfizer and Valneva announced that “a significant percentage of participants” enrolled in the VALOR study was “discontinued.”

“These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator,” Pfizer said in a statement.

According to Reuters, “The decision could delay the time to approval of a vaccine that Valneva expects could become a blockbuster shot.” Quoting brokerage firm Rx Securities, Reuters reported that as many as 2,000 participants were affected.

Despite this potential delay, “Pfizer still expects to submit marketing applications for the experimental vaccine in the United States and Europe in 2025.”

In April 2022, Pfizer announced that Phase 2 clinical trials of VLA15 delivered “positive” results, including among pediatric trial participants.

“VLA15 has demonstrated strong immunogenicity and safety data in pre-clinical and clinical studies,” Pfizer said at the time.

In Phase 2, Pfizer and Valneva tested the VLA15 vaccine at two different dosing levels: a two-dose regimen six months apart and a three-dose regimen with follow-up shots administered at two and six months after the initial administration.

Phase 2 participants included adults and children 5 to 17 years old — and more than 600 participants total.

The two companies reported no vaccine-related serious adverse events during the Phase 2 trial.

Pfizer previously faced difficulties during clinical trials for its vaccines. Whistleblower Brook Jackson sued the drugmaker and two other companies in January 2021, alleging she observed serious breaches during a clinical trial for the Pfizer-BioNTech COVID-19 vaccine.

The lawsuit was dismissed March 31, but Jackson plans to appeal.

Rutgers conducted COVID vaccine trials on children while mandating the vaccines for students

On Nov. 4, 2022, Rutgers was selected as a clinical trial site as part of the worldwide Pfizer-BioNTech research study evaluating the safety and efficacy of the bivalent COVID-19 vaccines in children under age 5.

This was not the first time Rutgers served as a COVID-19 vaccine clinical trial site. In 2022, the university conducted pediatric vaccine trials for Pfizer-BioNTech, and in 2021, it hosted trials for Moderna and Johnson & Johnson (Janssen).

In August 2021, Children’s Health Defense (CHD), along with 13 Rutgers students, sued the university, its board of governors, Rutgers President Jonathan Holloway and others over the university’s COVID-19 vaccine mandate for students.

Julio C. Gomez, lead counsel in the case, previously told The Defender the clinical trials are evidence of Rutgers’ conflicts of interest related to the university’s COVID-19 vaccine policies.

“As we alleged in our lawsuit, Rutgers was selected by all three vaccine manufacturers — Pfizer, Moderna, and Johnson & Johnson — to run clinical trials. Rutgers knew or should have known none of these studies showed that these vaccines prevent transmission, yet Rutgers rushed to be one of the first universities in the country to mandate COVID-19 vaccines on its students.”

On Sept. 9, 2022, a judge granted Rutgers’ motion to dismiss the lawsuit. In January, CHD filed an appeal with the U.S. Court of Appeals for the 3rd Circuit, seeking to demonstrate the court failed to accept the university’s allegations as true, which is the legal standard in a motion to dismiss.

CHD also argued that Rutgers did not have the authority to mandate vaccination — in particular, for an experimental drug.

On March 2, CHD submitted a reply brief to the appeals court, arguing the lower court erred when it dismissed the case. The case may eventually reach the Supreme Court.