Vaccine for Toxic Shock Syndrome Shows Promise in Clinical Trial – Verywell Health

Key Takeaways

Toxic shock syndrome (TSS) is a rare but potentially life-threatening condition thats caused by toxin-producing bacteria. When most people think of toxic shock, the first risk factor that leaps to mind is usually high absorbency tampons. But TSS isnt just linked to tampons or even menstruationanyone can develop it. If it goes untreated, TSS can lead to organ failure and even death.

New research from Austria has offered a glimpse into a future where it could be much easier to prevent TSS: with a vaccine.

The candidate vaccine, rTSST-1v, has completed a successful phase 2 clinical trial in which it showed it could offer protection for at least two years. Of the 126 participants in the study, more than 80% developed protection against TSS after the first dose.

The vaccine candidate is a detoxified version of TSST-1, the toxin responsible for 75% of all TSS cases, Andreas Roetzer, PhD, head of vaccine research and development at Biomedical Research & Bio-Products, told Verywell.

Staphylococcus aureus (staph) is often the cause of TSS, but Streptococcus pyogenes (strep) can also cause it.

Heres how the vaccine works and what the approval process could look like.

The TSS vaccine is designed to get the body to make neutralizing antibodies, which can prevent the onset of TSS. According to Roetzer, the neutralization aspect is key because it could stop symptoms and reduce the need for antibiotic treatment.

Depending on the expected efficacy of the vaccine, it could prevent all hospitalizations from TSS, Sharon Nachman, MD, a board-certified pediatric infectious disease specialist at Stony Brook Medicine, told Verywell.

The vaccines trial data has been promising so far, showing that most participants had a four-fold increase in antibodies after getting the first round of the vaccine (seroconversion). And 18 months later, over 85% of participants had protection after getting the third shot.

If approved, the TSS vaccine would be given intramuscularly, like a tetanus shot. Roetzers team plans to do follow-up trials 60 months after the initial vaccination and expects that a two-dose vaccine would be enough to provide life-long protection.

While Roetzer said that toxic shock syndrome is relevant for premenopausal women as soon as menarche (menstruation) starts, the vaccine is intended for everyone.

Since using menstrual products like tampons is a known risk factor for TSS (and menstrual toxic shock syndrome is used to differentiate it from other risk factors), young teens would likely be one of the priority groups for the vaccine.

Testing the efficacy and safety of a TSS vaccine could take several years, according to Nachman. A lot of the timing will depend on who the key populations are determined to be. For example, a study focused on preventing TSS in teens who are just starting to have periods would require observing how well the vaccine works over a fairly long time.

Nachman said that the vaccine would also need to undergo a phase 3 clinical trial to prove that its safe and effective at preventing TSS on a larger scale. That part of the trial would typically involve several hundred to several thousand patients.

While we dont have a vaccine yet, there are treatments for TSS, including:

Its also important to remember that TSS doesnt just affect women who have menstrual cyclesit can strike patients with weak immune systems, chronic wound infections, chronic illness, and people having surgery. An approved TSS vaccine would likely reduce the need for antibiotics and prevent hospitalizationsand could even save lives.

Toxic shock syndrome (TSS) isnt just linked to tampons; it can happen to anyone, including people with chronic wounds and illnesses, as well as those having surgery. A vaccine for TSS is in the works and could someday help prevent the potentially life-threatening infection.

National Library of Medicine: MedlinePlus. Toxic shock syndrome.

Schoergenhofer C, Gelbenegger G, Hasanacevic D, et al. A randomized, double-blind study on the safety and immunogenicity of rTSST-1 variant vaccine: phase 2 results. EClinicalMedicine. 2024;67:102404. doi:10.1016/j.eclinm.2023.102404

TeensHealth. Toxic shock syndrome.

Billon A, Gustin MP, Tristan A, et al. Association of characteristics of tampon use with menstrual toxic shock syndrome in France. EClinicalMedicine. 2020;21:100308. doi:10.1016/j.eclinm.2020.100308

Centers for Disease Control and Prevention. Streptococcal toxic shock syndrome.

By Kayla Hui, MPH Kayla Hui, MPH is the health and wellness ecommerce writer at Verywell Health.She earned her master's degree in public health from the Boston University School of Public Health and BA from the University of Wisconsin-Madison.

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Vaccine for Toxic Shock Syndrome Shows Promise in Clinical Trial - Verywell Health