We have some good news today, the Valneva Lyme disease vaccine, which will be distributed by Pfizer, is going to commence phase 3 clinical trials in the USA and Europe. For those of you who live in areas where Lyme disease is endemic, I’m sure you can’t wait.
This article will quickly review Lyme disease, the new vaccine, and how you might be able to volunteer for the clinical trials. Yes, you might be able to volunteer for the phase 3 clinical trials.
What is Lyme disease?
Lyme disease is an infectious disease caused by at least three species of bacteria belonging to the genus Borrelia. Of the three species, Borrelia burgdorferi is the main cause of Lyme disease in North America, whereas Borrelia afzelii and Borrelia garinii are more prevalent in Europe. The disease was named after the towns of Lyme and Old Lyme, Connecticut, where several cases were initially identified in 1975.
Borrelia is transmitted to humans when bitten by infected ticks which belong to a few species of the genus Ixodes, called “hard-bodied” ticks. Although deer ticks, Ixodes scapularis, Ixodes pacificus, or Ixodes ricinus, are commonly considered to be the vectors for Borrelia infection, some of the other species in the Ixodes genus can transmit the disease. Lyme disease is the most common tick-borne disease in the United States.
There are several initial symptoms of Lyme disease – fever, headache, fatigue, depression, and a circular skin rash called erythema migrans (EM). If the Borrelia infection is not treated quickly, further symptoms may appear that can involve the joints, heart, and central nervous system.
There is generally only one known treatment for a Borrelia infection – antibiotics, which may include doxycycline, amoxicillin, and cefuroxime. Generally, the symptoms of the infection resolve after antibiotic treatment.
While the true incidence of Lyme disease is unknown, it is estimated to affect approximately 476,000 people annually in the USA and 130,000 people in Europe.
As I’ve written previously, the existence of “chronic Lyme disease,” a condition that some claim is a set of vague symptoms that are claimed to be a consequence of a permanent B. burgdorferi infection and somehow persists after antibiotic therapy. The existence of chronic Lyme disease is not supported by robust scientific evidence published in peer-reviewed, high-impact-factor biomedical journals.
The Pfizer-Valneva Lyme disease vaccine
Without a doubt, we need a Lyme disease vaccine, because the infection is debilitating and takes some significant effort by medicine to diagnose and treat the disease. According to a Nature editorial,
It may go against the scientific grain for marketing considerations to play such a part in steering vaccine development. But in the real world, this may be unavoidable. Lyme disease is a serious illness and those who live in areas where it is spreading deserve a vaccine.
Luckily for those in areas with endemic Lyme disease, a small French vaccine company, Valneva, has been developing a new Lyme disease vaccine, code-named VLA15. According to Valneva’s website, VLA 15 is a multivalent vaccine that targets one of the most dominant outer surface proteins of Borrelia. Valneva has partnered with Pfizer to complete clinical trials and to bring the vaccine to the market in North America and Europe.
Preclinical studies showed that the vaccine was broadly effective against Borrelia. These types of studies are how most vaccines are developed, by trying them in animal models.
Soon thereafter, Phase 1 clinical trials, in which the vaccine is tested on healthy volunteers, were successful. Valneva proceeded with two Phase 2 clinical trials.
Valneva has reported that the Lyme disease vaccine candidate was immunogenic across all dosages. They also found that the results did not indicate that prior exposure to Lyme disease had an impact on immunogenicity or safety.
The seroconversion rates (SCR) ranged from 85.6% to 97%. The immunological response in older adults, one of the main target groups for a Lyme vaccine, is particularly encouraging, stated the company.
Now, as I’ve written extensively regarding the rush for a coronavirus vaccine, we should reserve any optimism until the results are published in a peer-reviewed journal. And seroconversion does not necessarily mean immunity, although it would strongly indicate that.
VLA15 was granted a Fast Track designation by the FDA in July 2017. Because this designation is often misunderstood, I’ll try to explain it. Fast Track is granted by the FDA to investigational products that are under development for serious conditions and have the potential to fulfill an unmet medical need (in other words, the Lyme disease vaccine is a perfect example).
The process facilitates clinical development and expedites the review of new drugs and vaccines. It accelerates the availability of promising products on the market.
This does not mean that the vaccine gets less than a thorough review. It does not mean that Valneva and Pfizer can skip any of the phases of human clinical trials. Fast Track speeds up the review process. The process does not become easier.
Phase 3 clinical trial
Valneva and Pfizer announced on 9 August 2022 the initiation of Phase 3 clinical trials, Vaccine Against Lyme for Outdoor Recreationists (VALOR), to investigate the safety, effectiveness, and immunogenicity of the Lyme disease vaccine candidate VLA15. As of today, VLA15 is the only Lyme disease vaccine that is currently in clinical development
Pfizer and Valneva are going to recruit approximately 18,000 healthy participants 5 years and older from areas with high levels of endemic Lyme disease to receive the VLA15 vaccine or a placebo. Just to be utterly clear, each participant will have about a 50% chance of receiving VLA15 and about a 50% chance of receiving a placebo. A subset of participants will receive VLA15 from 3 different lots or a placebo (1:1:1:3 ratio) to assess lot equivalence. The participants will have to receive three doses of VLA15 (180 µg).
The study will be conducted at up to 50 sites in areas where Lyme disease is highly endemic, including Poland and parts of the USA. The USA study centers are in Connecticut, Massachusetts, New Jersey, New York, Pennsylvania, and Rhode Island.
Pending successful completion of the Phase 3 study, Pfizer could potentially submit a Biologics License Application to the U.S. FDA and Marketing Authorisation Application to the European Medicines Agency in 2025. It’s going to be a few years before the vaccine becomes available widely.
How to join this clinical trial?
Although I am uncertain of the breakdown, I’m guessing that about ⅔ of the participants will be in the USA (since the disease is more prevalent in that country) and about ⅓ in Europe. However, I am not sure, so don’t hold me to that.
A participant needs to be 5 years and older. They also have to meet the following inclusion and exclusion criteria:
Key Inclusion Criteria:
- Participants who reside in areas with endemic Lyme disease and who lead lifestyles that put them at increased risk for Lyme disease. For example, this could include, but not be limited to:
- Individuals who work in B burgdorferi-infected/tick-infested areas, especially those with occupations that may be associated with a higher risk of exposure, such as landscaping, forestry, and wildlife and parks management.
- Individuals who pursue recreational activities such as hiking, camping, fishing, hunting, jogging, or gardening in such areas.
- Individuals who live on land plots with tree lines and who come into contact with these trees regularly.
- Individuals who have dogs that regularly are outdoors and frequently return with attached ticks.
- Individuals who participate in activities in areas with tall grass, smaller wooded areas beside forests, open fields, lakesides, and riversides.
Key Exclusion Criteria:
- Any diagnosis of Lyme disease within the past 3 months.
- Any history of Lyme carditis, neuroborreliosis, or arthritis, regardless of when diagnosed.
- Known tick bite within the past 4 weeks.
- Newly developed or unstable underlying conditions that may interfere with the assessment of Lyme disease, including but not limited to chronic arthralgia/arthritis, second/third-degree AV heart block, chronic pain syndromes, and chronic skin conditions that reduce the ability to detect cutaneous manifestations of Lyme disease.
- Any autoimmune condition with a manifestation (eg, arthritic and neurologic) that may interfere with the assessment of Lyme disease.
- The use of chronic systemic doxycycline or minocycline or other tetracycline-class drugs for acne or any other chronic suppressive antibiotics used to treat other conditions.
So, if you meet those criteria, live in the areas where study centers are located, and be willing to participate in a double-blind, randomized clinical trial, then contact Pfizer at ClinicalTrials.gov_Inquiries@pfizer.com. It’s simple as that.
Now, you must remember you have a 50% chance of getting a placebo, and you cannot demand to be in the vaccine group. That would break the randomization and the double-blind nature of the study.
However, and I cannot guarantee this, the placebo group often receives the real vaccine after the study closes. Even if you’re in the placebo group, you might end up getting the real vaccine well before the rest of us do.
Good luck. And maybe drop a comment if you’ve signed up or have been included. It would be interesting to find out how many of you want this vaccine. If I lived in an endemic area, I would love to participate.
This clinical trial will make so many people very happy who worry about the disease.
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