Mode
Text Size
Log in / Sign up

LC16m8 pre-exposure prophylaxis showed no mpox cases in a randomized controlled trial of high-risk adultsMpox Vaccine Shows Promise for High-Risk Groups, But Key Questions Remain

AI-generated summary of the cited source, checked by automated accuracy review. How we work

Key Takeaway
Note that LC16m8 showed no mpox cases, precluding efficacy calculations in this randomized controlled trial.

This multicenter randomized controlled trial evaluated LC16m8 pre-exposure prophylaxis in men and women aged 18 years or older at high risk of mpox. Participants were randomized 1:1 to receive early or late vaccination. The study population included individuals with and without HIV.

The primary outcome was vaccine efficacy against mpox. No mpox cases occurred in the study, with 0 cases reported in the early-vaccination group and 0 cases in the late-vaccination group. Consequently, vaccine efficacy could not be calculated. Take rates were 89.5% for participants with HIV and 93.9% for those without HIV.

Seroconversion rates for LC16m8 were 96.2% in participants with HIV and 92.0% in those without HIV. Seroconversion rates for MPXV were 69.2% with HIV and 52.0% without HIV. Serious adverse events occurred in 2 of 352 participants with HIV (0.6%) and 3 of 654 participants without HIV (0.5%). One causally related serious adverse event occurred in a participant without HIV. No fatal adverse events were observed.

Adverse events occurred in 97.2% of participants with HIV and 98.2% of participants without HIV. The study raised no significant safety concerns in individuals with well-controlled HIV. A key limitation is the absence of mpox cases, which precludes definitive efficacy calculations. The findings suggest suitability for targeted vaccination of at-risk groups, though efficacy remains inconclusive.

The Mpox Threat Isn't Over

Remember the 2022 mpox outbreak? It spread fast, mostly among men who have sex with men, and caught the world off guard. For many, the painful rash, fever, and swollen lymph nodes were more than uncomfortable. They were scary.

Now, a new vaccine called LC16m8 is getting attention. And for good reason. It was tested in the exact group that needs protection most: people at high risk of catching mpox.

But here's the thing. The trial didn't actually prove the vaccine stops mpox. No one got sick during the study. That sounds like good news. But it also means researchers can't calculate how well the vaccine works.

So what did they learn? A lot, actually.

What Makes This Vaccine Different

Older mpox vaccines exist. But they have limits. Some aren't recommended for people with certain health conditions. Others require special handling or multiple doses.

LC16m8 is a live, weakened vaccine. Think of it like a training exercise for your immune system. The vaccine carries a harmless version of the virus. Your body learns to recognize and fight it. If the real mpox virus shows up later, your immune system is ready.

The key question was whether this would work in people with HIV. Their immune systems are already under strain. Would the vaccine still trigger protection?

The Trial in Plain Numbers

Researchers in Japan enrolled over 1,100 adults at high risk for mpox. Most were men. About one in three had HIV. All had their HIV well-controlled with medication.

Half got the vaccine early. The other half got it later. This setup let researchers compare outcomes.

The results were encouraging. Among people without HIV, nearly 94% developed a visible "take" reaction. That's a small skin response that shows the vaccine is working. For people with HIV, the rate was still high at nearly 90%.

This doesn't mean the vaccine is ready for widespread use yet.

Blood tests told a similar story. Over 92% of people without HIV developed antibodies against the mpox virus. So did over 96% of those with HIV. Those numbers are strong.

The Safety Picture

Vaccines need to be safe. Especially for people with weakened immune systems.

Most participants reported some side effects. That's normal with any vaccine. Think sore arm, mild fever, tiredness. Nothing unexpected.

Serious side effects were rare. Only about half a percent of participants had them. And only one case was linked to the vaccine itself. That person did not have HIV.

No one died from the vaccine. That matters.

But There's a Catch

Here's the honest truth. No one in the study got mpox. Not in the early vaccination group. Not in the late vaccination group.

That sounds perfect. But it creates a problem. You can't prove a vaccine prevents a disease if no one gets the disease. The math doesn't work.

Why didn't anyone get sick? It could be because the vaccine worked. Or it could be because mpox cases dropped in Japan during the study. Or both.

Researchers call this "inconclusive." It's not a failure. It's just incomplete.

If you're at high risk for mpox, this vaccine may eventually be an option. The data suggests it's safe and triggers strong immune responses. Even in people with well-controlled HIV.

But don't rush to your doctor yet. This is one trial. More research is needed. And the vaccine isn't widely available outside Japan.

If you're concerned about mpox, talk to your healthcare provider about currently approved vaccines. They may have options that work for you.

What Happens Next

Researchers need a bigger study. One where mpox is still spreading. That would let them measure real-world protection.

They also want to see how long the immune response lasts. Six months? A year? Longer? We don't know yet.

For now, LC16m8 looks promising. But science moves carefully. And that's a good thing. You want a vaccine that's been thoroughly tested before you roll up your sleeve.

Study Details

Study typeRct
Sample sizen = 565
EvidenceLevel 2
Follow-up216.0 mo
PublishedApr 2026
View Original Abstract ↓
BACKGROUND: This randomized controlled trial provided LC16m8 pre-exposure prophylaxis to high-risk individuals to assess its efficacy for mpox prevention, safety, and immunogenicity. METHODS: This multicenter, randomized, open-label trial enrolled men and women aged ≥18 years at high risk of mpox. Participants were randomly assigned 1:1 to early- or late-vaccination groups. The primary endpoint was vaccine efficacy (VE) against mpox. Secondary endpoints included VE against severe mpox, symptoms, "take" incidence, adverse events (AEs), and immunogenicity in participants with human immunodeficiency virus (HIV). RESULTS: In total, 570 and 565 participants were assigned to early- and late-vaccination groups, respectively, with 530 and 476 vaccinated. The median age was 41 years; 99.7% were male, 89.7% were Japanese, and 34.4% had HIV. No mpox cases occurred, precluding VE calculations. The take rates were 89.5% (with HIV) and 93.9% (without HIV). AEs occurred in 97.2% and 98.2% of participants with and without HIV, respectively. No fatal AEs were observed. Serious adverse events (SAEs) were observed in 2/352 (0.6%) and 3/654 (0.5%) of participants with and without HIV, respectively, of which 1 SAE causally related to vaccination occurred in a participant without HIV. Seroconversion rates for LC16m8 and MPXV were 96.2% and 69.2%, respectively, in participants with HIV, and 92.0% and 52.0%, respectively, in individuals without HIV. CONCLUSIONS: LC16m8 efficacy in mpox remains inconclusive. However, in individuals with well-controlled HIV, it was immunogenic and raised no significant safety concerns, suggesting its suitability for targeted vaccination of at-risk groups. (Japan Registry of Clinical Trials number, jRCT1031230137).
Free Newsletter

Clinical research that matters. Delivered to your inbox.

Join thousands of clinicians and researchers. No spam, unsubscribe anytime.